WARNING LETTER

Spectra Therapy, LLC MARCS-CMS 698026 — July 22, 2025

Delivery Method:: VIA Electronic Mail
Product:: Medical Devices

Recipient:: Recipient Name

John J. Stephan; Recipient Title

President & CEO; Spectra Therapy, LLC; 3350 Lapeer Road
Port Huron, MI 48060
United States; johnstephan@spectratherapy.com

Issuing Office:: Center for Devices and Radiological Health; United States

WARNING LETTER
CMS: 698026

July 22, 2025

Dear Mr. Stephan:

During an inspection of your firm located in Port Huron, MI on September 10, 2024, through September 13, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures therapeutic heating infrared lamps, marketed as the LASERwrap system. The LASERwrap system includes the Spectra A-100 Impulse Laser Unit and accessories such as filament wraps and pads that are applied to the body and connected to the Spectra A-100 Impulse Laser Unit. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.

Quality System Regulation Violation(s)

This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

We received a response from (b)(6), (b)(7)(C), dated September 24, 2024, but received October 3, 2024, on behalf of your firm, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include but are not limited to the following:

1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met to demonstrate that the design was developed in accordance with the design control requirements as required by 21 CFR § 820.30(a) through § 820.30(j). Specifically,

a. Your firm has not established procedures to control the design of the LASERwrap system.

b. Your untitled and undated design document provided during the inspection did not provide adequate detail or objective evidence to demonstrate how the specific specifications and operating modes listed in this document were developed, established, verified, and validated to ensure that device conforms to user needs and the proper functioning of the device. Further, your firm was unable to provide evidence that software validation and/or risk analysis were performed.

c. Several design changes have been made to the LASERwrap system that have not been verified and/or validated. For example, a design change to the housing (or case) of the A-100 Impulse Laser unit was made in 2021, and this design change was not verified and/or validated and was not conducted in accordance with any established procedure.

We reviewed your firm’s response and concluded that it is not adequate. This response promises development of a Product Design and Development procedure and plans to conduct (b)(4) audit of devices already sold. Your firm’s response does not address how it will establish a design plan, inputs, outputs, verification, and validation for the LASERwrap system. It also does not address reviewing the design changes made to the device to determine if verification and/or validation is required. In your firm’s response to this letter, please address these concerns and provide a copy of the promised procedure, complete documentation for all design control requirements of the LASERwrap system, and the outcome of the (b)(4) audit once these items are completed or a timeframe when these items will be provided.

2. Failure to establish and maintain procedures to control product that does not conform to specified requirements. The procedures shall address the identification, documentation, evaluation, segregation, and disposition of nonconforming product. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented, as required by 21 CFR § 820.90.

Specifically, your firm has not established a procedure to control nonconforming product found during final acceptance activities. For example, when a laser is found to not conform to specified requirements as part of your final functional testing, your manager stated that it is placed into a “Lasers need repair” bin with details related to the nonconformance occasionally captured on pieces of (b)(4) paper. This bin is subsequently returned to your firm’s contract manufacturer to perform investigation and repair without documentation of these activities.

Your firm’s response did not address this violation that was presented as a discussion item during the inspection. In response to this letter, please provide any completed actions taken by your firm to address this item or your planned actions and the timeframe for when these actions will be completed.

3. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR § 820.100.

Specifically, your firm’s corrective and preventive procedure, BSP-05 Corrective and Preventative Actions Procedure, has not been implemented and remains in a draft status.

We reviewed your firm’s response and concluded that it is not adequate. In this response your firm indicates that it plans to complete and initiate a “Corrective Action/Preventive Action” (CAPA) procedure to address this observation. Please provide this procedure for our review.

4. Failure to maintain an adequate record of investigation as required by 21 CFR § 820.198(e). The record of investigation shall include:

a. The name of the device;
b. The date the complaint was received;
c. Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used;
d. The name, address, and phone number of the complainant;
e. The nature and details of the complaint;
f. The dates and results of the investigation;
g. Any corrective action taken; and
h. Any reply to the complainant.

Specifically, your firm has failed to document investigations performed by your firm and/or contract manufacturers utilized by your firm that contain the above required information. For example, you provided a “(b)(4)” spreadsheet that your firm utilizes to log complaints received as well as lasers returned to your firm. This document contains approximately (b)(4) lines of complaints received over a (b)(4)-month period. However, this document is not being adequately maintained in that several rows are blank and missing the above required information.

5. Failure to evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to meet specified requirements, including quality requirements. The evaluation shall be documented, as required by 21 CFR § 820.50(a)(1).

Specifically, your firm’s purchasing control procedure (BSP-03 Purchasing Controls Procedure; no Rev.; no date) includes the following requirements:

a. Section 4.2.1C requires a copy of the vendor’s ISO 134865 or ISO 9001 certification of registration OR results of the vendor’s self-assessment conducting in accordance with their Quality Management System.

Documented proof of these documents or any other documented vendor selection and evaluation was not provided.

b. Section 4.4.1 of your purchasing control procedure requires your firm to perform (b)(4) vendor evaluations to review the suppliers’ performance.

Documented incidences of periodic reviews being conducted were not provided.

However, despite no initial or periodic evaluation of your suppliers being performed, all suppliers are listed as ‘Active’ on your firm’s qualified supplier list (Production Supplier List; Effective 9-1-2024).

6. Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR § 820.80(d).

Specifically, your firm’s manager explained that she is responsible for performing (b)(4) testing of finished devices. This process and activities are not performed according to an established procedure or work instruction, nor are the results of these activities documented.

We reviewed your firm’s response and concluded that it is not adequate. Your firm’s response indicates it will create documents for acceptance activities. Please provide these acceptance activity documents for our review.

7. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR § 820.22.

Specifically, your firm has not established procedures for quality audits, nor have you conducted a quality audit since your firm began manufacturing devices in 2008.

We reviewed your firm’s response and concluded that it is not adequate. In this response you indicate that your firm will initiate a quality audit as soon as possible and provide procedures and associated forms (“Quality Audits”) with an estimated completion date of 11-29-2024. However, these promised documents have not been provided. In your response to this letter, provide the promised forms or a date that they will be provided. Additionally, provide evidence of a quality audit or the date one is planned.

8. Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure that the quality system satisfies the requirements of this part and the manufacturer's established quality policy and objectives, as required by 21 CFR § 820.20(c).

Specifically, your firm has not established procedures for conducting management reviews nor have you conducted a management review since your firm began manufacturing devices in 2008.

We reviewed your firm’s response and concluded that it is not adequate. In this response you indicate that your firm will provide procedures and associated forms (“Management Review”) with an estimated completion date of 12-31-2024. However, these promised documents have not been provided. In your response to this letter, provide the promised forms or a date that they will be provided. Additionally, your response does not address if your firm plans to conduct a management review. Please explain if one has been conducted or the date one is planned.

9. Failure to establish and maintain procedures to control all documents, as required by 21 CFR § 820.40.

Specifically, your firm has not established procedures to control documents (policies, procedures, forms, etc.) utilized by your firm for the operations related to medical devices manufactured by your firm.

We reviewed your firm’s response and concluded that it is not adequate. In this response your firm indicated that it would complete and initiate a “Document Control” procedure with an estimated completion date of 12-31-2024. In your response to this letter, provide the promised document or a date that they will be provided.

10. Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented, as required by 21 CFR § 820.25(b).

Specifically, your firm has not established a training procedure nor has training been documented for any employee.

Unapproved Device Violation(s)

Our inspection also revealed that the LASERwrap system is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g), for the device as you market it.

The LASERwrap system is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution this device, intended for a use different from the intended use of a legally marketed device in the generic type of device described under 21 CFR 890.5500 Infrared lamp without submitting a premarket notification to FDA as required by section 510(k) of the Act and 21 U.S.C. § 360(k).

Devices classified under 21 CFR 890.5500 Infrared lamp are exempt from premarket notification unless they exceed the limitations on exemption at 21 CFR 890.9(a). Generic devices of this type emit energy at infrared frequencies (approximately 700 to 50,000 nanometers) to provide topical heating and are intended for medical purposes including, but not limited to, temporary increase in local blood circulation and temporary relief of: muscle spasms, minor joint pain and stiffness, minor muscle pain and stiffness, and minor arthritis pain.

There is evidence that the LASERwrap system is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5500 (Infrared lamp). Based on the user manual collected during the inspection and a review of your firm’s website, https://spectratherapy.com/human-treatable-%20%20%20conditions/ (accessed July 9, 2025) your firm is marketing the LASERwrap system for different intended uses, including treatment of diseases or conditions such as irritable bowel syndrome, wounds, and urinary tract infections, and cure of “inflammatory issues” such as tendonitis, bursitis, and plantar fasciitis. For example, the product user manual includes the following claims:

• “The Physiological Effects of [Low-level laser therapy] LLLT are:
1. Bio-stimulation
 Improved metabolism
 Increase of cell metabolism
. . .
5. Stimulation of wound healing…”

• “How has LLLT worked for others? . . .
o Increases . . . tensile strength of tissue repair
o Stimulates the immune system and nerve function
o Develops collagen ...
o Promotes faster wound healing and clot formation ...”

• “Abdominal & Back LASERwrap® Treatments ...
o Reduce IBS [Irritable Bowel Syndrome] & UTI [Urinary Tract Infection]”

Your website also https://spectratherapy.com/human-treatable-%20%20%20conditions/ includes the following statements:

• Under “Wounds” your website provides the following testimonial: “LASERwrap® eliminated PAIN from 7 patients in less than a week to 10 days, that had been fighting neuropathy & plantar fasciitis conditions from 6 MONTHS to 2 YEARS. Good news for lower extremity diabetic patients with wounds on the bottom of their feet, LASERwrap® healed decubitus wounds in 2 weeks versus 4-5 months using conventional debriefing methods.”

• Under “Chronic Pain” your website provides the following testimonial: “This laser has a multiplicity of effects. It can cure both acute and chronic inflammatory issues including tendonitis, ankle sprains, bursitis, plantar fasciitis and back strain all without the use of anti-inflammatory or pain medicine. It can markedly decrease the pain of neuropathy in the lower extremeities [sic] and improve restless leg syndrome to the pint [sic] where patients can eliminate medication. It can decrease the time it takes to heal stasis and vascular ulders [sic]...”

• Under “Fibromyalgia” your website provides the following testimonial: “...The most common types include osteoarthritis (OA), rheumatoid arthritis (RA), psoriatic arthritis (PsA), fibromyalgia and gout. Since all of them cause pain in different ways, LASERwrap® treats a large AREA of concern, rather than just a small spot of interest, providing improved circulation around the entire extremity, across shoulders & neck or entire lower back & sciatica area.”

• Fractures
• Insomnia
• Migraines
• Oral...Pain
• Respiratory (COPD)
• Spine Injuries
• TMJ/TMD Disorder

Because there is evidence as described above that the LASERwrap system is intended for uses that are different from those of legally marketed devices classified under 21 CFR 890.5500, the device exceeds the limitations described in 21 CFR 890.9(a) and is not exempt from premarket notification.

Further, FDA cleared a 510(k) (K080689) for the “Spectra Therapy Spectra A1000 Laser Device” on July 9, 2008, with the following indications for use: “The Spectra Therapy Spectra A1000” is an infrared lamp intended to provide topical heating . . . [and] is indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.” However, the statements in your firm’s user manual for the LASERwrap system and on your firm’s website provide evidence that the device is intended to treat diseases or conditions such as irritable bowel syndrome, wounds, and urinary tract infections, and to cure “inflammatory issues” such as tendonitis, bursitis, and plantar fasciitis, which would constitute a major change or modification to the intended use of the device cleared under K080689, for which your firm lacks clearance or approval. Examples of these statements are included above.

Your firm has provided no evidence to FDA supporting the above listed claims. The lack of supporting information demonstrating the safety and effectiveness of your device raises public health concerns, including the risk of a delay in definitive treatment if the LASERwrap systems are used as advertised. For example, delayed or ineffective treatment for wound care can lead to tissue death, infection, amputation, or death. Additionally, delayed or ineffective treatment of neuropathy can lead to permanent nerve damage and loss of function.

Your firm’s response did not address your firm’s marketing of the LASERwrap system for intended uses that are different from the intended use of legally marketed devices classified under 21 CFR 890.5500.

For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 CFR 807.81(b). The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

Medical Device Reporting (MDR) Violation(s)

Our inspection also revealed that your firm failed to adequately develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. A device is deemed to be misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), if there is a failure or refusal to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting.

During the inspection, your firm identified the document titled “BSP-02 Medical Device Reporting (MDR) Procedure,” undated, as its written MDR procedure.

After reviewing the procedure, the following deficiencies were noted:

1. BSP-02 Medical Device Reporting (MDR) Procedure does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements, as required by 21 CFR 803.17(a)(1). For example:

a. There are inadequate definitions of what constitutes a reportable event under 21 CFR Part 803. The fact that your procedure does not include definitions from 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” “malfunction,” “MDR reportable event,” and “serious injury,” and the definition for the term “reasonably suggests,” found in 803.20(c)(1) may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).

b. There are no instructions for how the firm will evaluate information about an event to make MDR reportability determinations in a timely manner.

2. BSP-02 Medical Device Reporting (MDR) Procedure does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part, as required by 21 CFR 803.17(a)(2). For example:

a. There are no instructions for conducting an investigation of each MDR reportable event and evaluating the cause of the event as required under 21 CFR 803.50(b)(3).

b. BSP-02 Medical Device Reporting (MDR) Procedure, as written, does not specify who makes the decision for reporting events to FDA.

3. BSP-02 Medical Device Reporting (MDR) Procedure does not establish internal systems that provide for timely transmission of complete medical device reports, as required by 21 CFR 803.17(a)(3). Specifically, the following are not addressed:

a. Instructions for how to obtain and complete the MedWatch for Industry FDA 3500A form, including which sections of the 3500A form will need to be completed to include all the information found in the firm’s possession and any information that becomes available as a result of a reasonable follow-up within the firm.

b. The circumstances under which the firm must submit an initial report, supplemental or follow-up report, 5-day reports and the requirements for such reports.

c. A process for submitting initial reports and supplement or follow-up reports to FDA in an electronic format that FDA can process, review, and archive in accordance with 21 CFR 803.12(a)¹.

4. BSP-02 Medical Device Reporting (MDR) Procedure does not describe how the firm will address documentation and record-keeping requirements, as required by 21 CFR 803.17(b), including:

a. Documentation of adverse event related information maintained as MDR event files.

b. Information that was evaluated to determine if an event was reportable.

c. Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable.

d. Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.

Your firm’s response did not include actions that you have completed, nor did it include information addressing the procedural deficiencies listed above. Instead, your firm listed planned actions, only one of which listed a date, December 31, 2024, by which the firm would “attempt” to complete and initiate a “Product Design and Development” procedure.

Unique Device Identification Violation(s)

The LASERwrap system is also misbranded within the meaning of section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, respecting these devices. In particular, 21 CFR 801.20(a) requires, with exceptions not relevant here, that the label and device package of every medical device bear a unique device identifier (UDI) that meets the requirements of 21 CFR Part 801, subpart B, and 21 CFR Part 830. Also, 21 CFR 830.300(a) and 830.320(b) – both of which were promulgated under section 519 of the Act, among other provisions – require that the labeler of a device submit electronically to FDA’s Global Unique Device Identification Database (GUDID) the information required by 21 CFR Part 830, subpart E, for each version or model required to bear a UDI. FDA has determined that your firm causes a label to be applied to a device with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label. Spectra Therapy, LLC is therefore a “labeler” within the meaning of 21 CFR 830.3 and has not submitted to GUDID any information required by 21 CFR Part 830, subpart E, respecting these devices.

The failure or refusal to furnish any notification or other material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, also constitutes a prohibited act under section 301(q)(1)(B) of the Act, 21 U.S.C. § 331(q)(1)(B).

Our office requests that Spectra Therapy, LLC cease any activities that result in the misbranding or adulteration of the LASERwrap system such as the commercial distribution of the device for the uses discussed above.

Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.

Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.

Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.

Your firm’s response should be sent via email to Establishment Assessment Team 1 Assistant Director Gina Brackett at CDRHEnforcement@fda.hhs.gov. Please include in the subject line CMS Case 698026 when replying. If you have any questions about the contents of this letter, please contact: Sean Moynihan at sean.moynihan@fda.hhs.gov.

Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.

Sincerely,
/S/

Matthew G. Hillebrenner
Deputy Director
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

_____________________

1 Information about the Final Rule for eMDR and the eMDR set-up process can be found on the FDA website at: eMDR – Electronic Medical Device Reporting | FDA