WARNING LETTER

Technological Medical Advancements LLC MARCS-CMS 712715 — September 26, 2025

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

Recipient:: Recipient Name

Dr. Bruce R. Coren, DVM, MS; Recipient Title

Chief Executive Officer; Technological Medical Advancements LLC; 1601 Belvedere Rd Ste E-180
West Palm Beach, FL 33406-1541
United States; bcoren@diowavelaser.com

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

WARNING LETTER

CMS # 712715

September 26, 2025

Dear Dr. Coren:

During an inspection of your firm located in West Palm Beach, Florida from April 9, 2025, through April 21, 2025, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Diowave 250 WLS and Diowave 100 WLS laser system. 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 any function of the body.

Unapproved Device Violations

FDA has reviewed the information collected during the April 2025 inspection and information on your firm’s website at www.diowavelaser.com (last accessed on July 1, 2025). FDA has reviewed the Physician Brochure (TMA, Physician Brochure, February 2024), AI Instructions for Use (TMA, Diowave 100 WLS & Diowave 250 WLS, IMPOS-AI User Instructions, Undated, 1 page.pdf ), Diowave Life Without Pain Brochure (Diowave Laser Treatment Center, Imagine Life Without Pain Brochure), and an Operating Manual (TWA, Diowave Stealth Micro-Pulse Laser System Operating Manual Version 2024-5), and has determined that the Diowave 100 WLS and Diowave 250 WLS devices are 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 described and marketed. The Diowave 100 WLS and Diowave 250 WLS devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. §360(k). Specifically, the Diowave 100 WLS and the Diowave 250 WLS are in violation of the Act for the reasons discussed below.

Technological Characteristics: Devices classified under 21 CFR 890.5500 Infrared Lamp are devices intended for medical purposes that emits energy at infrared frequencies to provide topical heating and are exempt from premarket notification requirements unless they exceed the limitations on exemption at 21 CFR 890.9. However, there is evidence that the Diowave 250 WLS and Diowave 100 WLS operate using a different fundamental scientific technology than that generic type of device. Specifically, your firm’s Care Provider Brochure states that “all heat during a stealth treatment is inhibited, allowing for deep penetration as there is no heat during treatment.” Further, the Diowave 100 WLS and Diowave 250 WLS appear to utilize stealth micro-pulse laser technology, which does not provide topical heating. For example, your distribution includes materials with claims such as:

o “Diowave is pleased to reveal the Stealth Micro-Pulsed Laser System™. SMPLTallows you to hold a hand piece static over a focal pathology without heating tissue..”
o “Our Stealth Micro-Pulse Technology allows care providers to treat various pathologies by Micro-Pulsing at appropriate power levels without introducing heat.”
o “The Doctor can remove all heat from the laser beam allowing him to hold thelaser directly over the injury for an indefinite amount of time.”

As shown by the evidence, the Diowave 100 WLS and Diowave 250 WLS devices do not provide topical heating. Instead, they use a different fundamental scientific technology. Therefore, the premarket notification requirements apply.

Intended Use:
Generic devices classified under 21 CFR 890.5500 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. Devices classified under 21 CFR 890.5500 are exempt from premarket notification unless they exceed the limitations on exemption at 21 CFR 890.9(a). However, there is evidence that the Diowave 250 WLS and Diowave 100 WLS are intended for uses that are different from the intended use of the type of devices classified under 21 CFR 890.5500 Infrared Lamp. For example, your distribution of the Diowave 100 WLS and Diowave 250 WLS devices includes the following claims:

o “a painless, non-surgical, and side-effective way to treat conditions previously refractive to traditional medical care”
o “treatment of various pathologies, including those refractive to traditional therapy”
o “Because laser therapy is the only treatment in medicine that actually heals living tissue, most conditions respond favorably to repeated laser therapy treatments. It has been proven to deliver results when all other forms of insurance-based medicine have failed.”
o “This technology has shown great promise in healing conditions which are refractive or non-responsive to all other forms of treatment and surgery, including HPLT [High Power Laser Therapy]”
o “peripheral neuropathy” case study: “An 80-year-old male with advance circulatory disease in his lower extremities presents with numbness in his feet and toes. He cannot drive because he cannot feel his feet…by the end of 12 visits, his proprioception to the bottom of his feet returned”
o “Summation of Various Main Treatment Indications for Diowave:…abdominalpain, pelvic pain, wound care”
o “Difficult to treat pathologies that are adequately treated by Diowave: post-surgical pain, implantable device pocket pain, surgically fused areas in which insurance will not cover further treatment, areas that do not respond well to nerve blocks or joint injections, “disc pathology, wounds refractory to conventional medical treatment, after regenerative medicine treatment: using laser to amplify effects of regenerative medicine treatments by kickstarting the process.”
o “results come from the laser’s ability to stimulate tissue growth and repair…results in accelerated wound healing with a dramatic decrease in…inflammation, and scar tissue formation”

Further, we note that your firm has an existing clearance (K121363) under 21 CFR 890.5500 with the following indications:

“The Diowave Laser System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.”

Your firm’s promotion of the device provides evidence that the device is intended for conditions beyond the indications for which it was cleared. Examples of these claims are included above. This constitutes a major change or modification in the intended use. Thus, a new premarket notification is required. Additionally, your firm’s promotion of the device provides evidence that your firm made a technological change to the device that could significantly affect the safety or effectiveness of the device. Examples of these claims are included above. This change is a significant change or modification for which a new premarket notification is required.

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/d efault.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.

Our office requests that Technological Medical Advancements LLC cease any activities that result in the misbranding or adulteration of the Diowave 100 WLS and Diowave 250 WLS devices, such as the commercial distribution of the device, for the uses discussed above.

Quality System Regulation Violations
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. Your firm’s response dated May 23, 2025, to the Form FDA 483 (FDA 483) was not received within fifteen business days of issuance of the FDA 483 however we performed a review of your response. These violations include, but are not limited to, the following:

1. Failure to adequately establish procedures to ensure that all purchased or otherwise received products and services conform to specified requirements, as required by 21 CFR 820.50.Specifically,

A. Your firm has failed to perform supplier evaluations as required by Purchasing Control Standard Operating Procedure, TMAQSP007, Revision 2.0. These include evaluations for critical suppliers, comprised of your contract manufacturer and designer (b)(4) and your contract service firm (b)(4), as required by Section 3 of your procedure. Additionally, no (b)(4) evaluations were conducted for any suppliers despite procedural requirements, and no justification was provided for not performing them.

B. Your firm failed to maintain supplier agreements as required by your Supplier Evaluation and Monitoring Standard Operating Procedure, TMA_QSP_023. For example, section 6.1.2 of your procedure states that “a Quality Agreement/Critical Supplier Quality Agreement is drafted and signed between both parties.” However, your firm has unsigned agreements with your contract manufacturer, including both the Critical Supplier Quality Agreement and Software Agreement. During the inspection, your contract manufacturer was unable to provide required design control records for review.

C. The inspection noted that your firm failed to have adequate purchasing controls and supplier oversight of your firm’s contract manufacturer, (b)(4), responsible for design controls. Your firm's inability to retrieve basic design control records from your contract designer/manufacturer during the FDA inspection, despite claims that these documents existed, demonstrates inadequate oversight of critical supplier activities. For example:

i. Your firm could not provide the Design History File (DHF) records for the Diowave 250 WLS and Diowave 100 WLS medical devices. The inspection found no evidence of essential design control records including design planning, design inputs, design outputs, design reviews, design verification, design validation, design change or design transfer, representing a comprehensive failure to maintain adequate design control records as required by FDA regulations. As such, FDA is concerned that the medical devices will not consistently meet intended use and safety requirements, that design changes are not properly controlled and documented, and that the finished device design may not meet user needs and intended use.

ii. The design risk management files for the Diowave 250 WLS and Diowave 100WLS laser device were not available for review. No records were available toreview by FDA investigators for design risk analysis despite your proceduralrequirements in section 3.4 of Risk Management Standard Operating Procedure,TMAQSP043, Revision 1.0, to incorporate risk analysis into your firm’s DesignReview. No risk assessment was available for review for the power increase from (b)(4)W to (b)(4)W. No evaluation on the potential need to submit a new premarket application was performed.

iii. Your firm’s Supplier Evaluation and Monitoring Standard OperatingTMA_QSP_023, Revision 1 states in section 6.2 that “(b)(4). ”There have been significant modifications to your devices without notification from critical supplier or oversight and approval of changes by your firm. This includes the review of design control records such as design verification and design validation to include risk analysis. For example, design control records for changes to software ((b)(4) for 250 WLS, (b)(4) for 100 WLS), as well as an identified power increase for the Diowave laser systems from (b)(4)W to (b)(4)W were not available for review during the inspection.

We reviewed your firm’s response dated May 23, 2025, and conclude that it is not adequate. Your firm’s response does not address deficiencies with the purchasing controls and oversight of the design control activities delegated to your contract manufacturer. In addition, while your firm provided some design control records from your contract manufacturer, (b)(4), you did not provide records that include the changes to the Diowave Laser System 100 WLS/250 WLS or design inputs, and therefore, we are unable determine if the device design outputs meet the design inputs. The design output records provided are missing complete device specifications, manufacturing specifications, software design specifications and labeling specifications. The design review documents are missing design reviews for all phases of the device design plan. There is no design change control for design changes previously described. The design transfer document does not include all required design transfer activities and any manufacturing process validations performed. Following our review of your response, you have not addressed the deficiencies in your firm’s design control subsystem and the requirement for a complete design history file (DHF) for your medical devices.

2. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit and to maintain complaint files, as required by 21CFR 820.198(a). For example:

A. FDA investigators reviewed ten complaints from 2025 and identified comprehensive procedural failures for the receipt, review, and evaluation of complaints. Your firm failed to implement Customer Complaints procedure, TMAQSP003, Revision 3.0,and perform required procedural activities for all complaints reviewed, including complaint investigations, failure mode analysis, Management Representative approval, and completing all fields in the complaint forms.

B. Your firm failed to handle all complaints in a timely manner. For example, your firm has not reviewed or evaluated (b)(4) servicing records from the third-party supplier as specified by your procedure TMA_QSP_009 Servicing, Rev 2.0, so that the Management Representative can determine if they meet the definition of a complaint so that they can be investigated as necessary.

We reviewed your firm’s response dated May 23, 2025, and conclude that it is not adequate. Specifically, your firm’s response does not address this inspectional observation, and therefore is missing a corrective action plan, time frames for implementation, and documentation of activities performed to correct the underlying deficiency.

3. Your firm has failed to adequately establish and maintain procedures for corrective and preventive action, as required by 21 CFR 820.100(a). Specifically, your firm has not adequately established CAPA Procedure, TMAQSP012, Revision 1.0. For example:

A. Your procedure lacks requirements for analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems.

B. Your firm has not implemented Section 3.2 of the CAPA procedure to identify actions needed to correct and prevent the recurrence of any non-conformity. For example, your firm has not opened any corrective and preventive actions, as required by your procedure, after it has been cited with the following:

i. Fourteen inspectional observations from an FDA inspection conducted from August 4, 2021, to September 9, 2021;
ii. Thirteen observations, along with seven verbal observations, from an FDA inspection conducted from February 19, 2020 to February 24, 2020;
iii. Twelve violations cited in a letter sent to your firm on June 8, 2020, by FDA.

This FDA inspection, along with previous FDA inspections, have identified repeat systemic deficiencies of your firm’s inability to identify actions to correct and prevent the recurrence of quality problems.

We reviewed your firm’s response dated May 23, 2025, and conclude that it is not adequate. Specifically, your firm’s response does not address the inspectional observation, and therefore is missing a corrective action plan, time frames for implementation and documentation of activities performed to correct the underlying deficiency.

4. Your firm has failed to establish and maintain adequate procedures for quality audits, as required by 21 CFR 820.22. Specifically, your firm did not conduct quality audits in 2023and 2024 as required by your Internal Audit Standard Operating Procedure, TMAQSP004,Revision 1.0. As of the date of the inspection, no quality audit has been conducted in 2025.

5. Your firm has failed to establish procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). Specifically, your firm does not have a procedure for addressing nonconforming products or materials. When the FDA investigator asked about procedures for nonconforming products or materials, you stated that such procedures did not exist. Without procedures to define nonconformance criteria and disposition processes, your firm cannot effectively identify or manage quality issues that may arise during manufacturing, incoming inspection, acceptance testing activities or as part of post-market surveillance activities.

6. Your firm has failed to adequately establish and maintain procedures for management review, as required by 21 CFR 820.20(c). Specifically, your firm did not follow Management Review Standard Operating Procedure, TMAQSP010, Revision 1.0, which requires periodic management review at least (b)(4). Your firm did not conduct a management review in 2024, thereby failing to determine the effectiveness of your quality system. This inspection identified several inspectional observations and deficiencies that have gone uncorrected from the two previous FDA inspections or approximately 5 years.

Unique Device Identifier Regulation (UDI) Violations

The inspection revealed that your devices are misbranded within the meaning of section 502(c) of the Act, 21 U.S.C. § 352(c), because a word, statement, or other information required by or under authority of section 519 of the Act, 21 U.S.C. § 360i, to appear on the label or labeling of the devices was not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. In particular, 21 CFR 801.20(a) – which was promulgated under authority of section 519 of the Act, among other provisions – 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. The labels of the Diowave Pure Pulse Laser System devices do not bear such a UDI.

Specifically, the labels for Diowave Pure Pulse Laser System devices do not include a device identifier within the meaning of 21 CFR 801.3 or 830.3, and there is no UDI presented in easily readable plain-text on the label of the device (see 21 CFR 801.40(a)(1)), and there is no UDI presented in machine-readable form that uses automatic identification and data capture (AIDC) technology on the label of the device (see 21 CFR 801.40(a)(2)).

A follow-up inspection will be required to assure that corrections and/or corrective actions are adequate. 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 Melissa Michurski, Assistant Director at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 712715” when replying. If you have any questions about the contents of this letter, please contact: Rafael Padilla at Rafael.Padilla@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/

Barbara C. Marsden
Acting Director
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health