Inspections, Compliance, Enforcement, and Criminal Investigations
CuraeLase, Inc. 12/9/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
DEC 9 2011
VIA UNITED PARCEL SERVICE
Mr. Roger D. Porter
5046 Hwy 17 Bypass, Suite 104
Myrtle Beach, South Carolina 29588
Dear Mr. Porter:
During an inspection of your firm located in Myrtle Beach, South Carolina, on March 29 through April 7, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the CL 1000 IR 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 are intended to affect the structure or function of the body.
Unapproved Device Violations
A review of our records shows that the CL 1000 IR Laser System was cleared on December 9, 2005, under K053201, with the following indications, “The CL1000 IR Laser System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.”
FDA reviewed the claims that your company is making for your devices, including information found on your firm’s website located at http://www.curaelase.com (most recently viewed on December 5, 2011) and an undated promotional brochure titled, "CURAELASE Laser Therapy For Pain," and has determined that your firm is marketing the device for the following indications:
"CuraeLase uses a unique wavelength that delivers photons to cells within the deep tissue. This decreases inflammation and edema, thus relieving pain .... "
"CuraeLase represents a quantum leap from traditionally used devices in the delivery of therapeutic monochromatic light. Laser light therapy dosing is measured in joules/cm2/second: and often comparisons are made using joules/cm2 for a particular treatment time (eg. 5 min., 10 min.). The CuraeLase device delivers a dose that exceeds any previously studied device by a factor of about 100. By virtue of this delivery system the tissue receives substantially higher energy and accordingly at a much deeper tissue level."
"Is it FDA Approved?" - "CuraeLase Laser Therapy is FDA approved to treat such acute and chronic pain conditions as fibromyalgia, diabetic neuropathy, plantar fasciitis, carpal tunnel, migraine headaches, as well as neck, knee and back pain."
"Patients with pain due to diabetic peripheral neuropathy come to the clinic having been treated with a variety of medications but with no substantial improvement. Patients receiving CuraeLase therapy experience the return of feeling, reduction of pain, as well as improved circulation to the extremities with the healing of wounds noted. A concentrated course of 8 treatments over a two-week period has proven to provide significant benefit in most cases."
These claims represent a major change in the intended use of the device under 21 CFR 807.81 (a)(3)(ii). Thus, the CL 1000 IR Laser System is adulterated under section 501 (f)(1)(B) of the Act, 21 U.S.C. § 351 (f)(1)(B), because you do 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g), for these changes. The CL 1000 IR Laser System is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution with these changes, as required by section 510(k), 21 U.S.C. § 360(k), and 21 CFR 807.81 (a)(3)(ii).
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 you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
Device Misbranding Violation
The CL 1000 IR Laser System device is also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), in that the promotional materials for the device, namely your website at http://www.curaelase.com and the above-referenced product brochure, contain statements that are misleading under 21 CFR 807.97, because such statements create an impression of official approval of a device due to clearance of a premarket notification submission. Specifically, the promotional literature states that the device is a "FDA-approved, noninvasive laser therapy." This device was not approved by the FDA, but was determined to be substantially equivalent within the meaning of section 513(i)(1)(A) of the Act, 21 U.S.C. § 360c(i)(1)(A), for the given indications only.
Medical Device Reporting Violation
Our inspection revealed that your firm's CL 1000 IR Laser System is misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused 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. These violations include, but are not limited to, the following:
Failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. Your firm has no written MDR procedures.
Your firm should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the awarding of contracts.
Electronic Product Radiation Control Violations
In addition to being a "device," the CL 1000 IR Laser System is an "electronic product" subject to compliance with Subchapter C of the Act, Electronic Product Radiation Control, the requirements at 21 CFR 1000-1005, and the performance standards at 21 CFR 1010, 1040.10, and 1040.11. Your firm failed to comply with the regulations regarding reports and record keeping. For example:
1. Your firm has introduced laser products into U.S. commerce without submitting a laser product report, as required by 21 CFR 1002.10.
2. Your firm has marketed laser products prior to June 30, 2011, and has not submitted an annual report by September 1, 2011, as required by 21 CFR 1002.13.
These violations are prohibited acts under section 538(a)(4) of the Act, 21 U.S.C. § 360oo(a)(4), which prohibits any manufacturer from failing or refusing to submit reports required pursuant to section 537(b) of the Act. Violations of section 538 are grounds for enforcement action under section 539 of the Act.
Copies of the Federal Performance Standards, compliance guides, radiation safety product report guides, and other documents related to laser products are available on FDA's web site at: http://www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/HomeBusinessandEntertainment/LaserProductsandlnstruments/default.htm.
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 correct 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 (including any systemic corrective actions) 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 all violations included in this Warning Letter.
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. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Quality System Regulation Concerns
We also note the following concerns regarding Quality System (QS) regulation requirements (21 CFR Part 820):
1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a)(1 ). For example, procedures for design controls have not been established.
2. Failure to adequately develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, as required by 21 CFR 820.70(a). For example, process control procedures that describe any process controls necessary to ensure conformance to specifications have not been adequately established.
3. Failure to adequately establish and maintain procedures for acceptance activities, as required by 21 CFR 820.80. For example, your firm has not adequately maintained its acceptance activities procedures. The (b)(4) which was a simple checklist, was the only written procedure that your firm was able to produce.
4. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, procedures for receiving, reviewing, and evaluating complaints by a formal designated unit have not been established.
5. Failure to adequately maintain device master record (DMRs), as required by 21 CFR 820.181. For example, there was no overall engineering drawing of the CL 1000 device, specified maintenance requirements, or actual numerical test results for tests containing a specific numerical test requirement. In addition, there was no formal device master record being kept by the firm. Documentation of the devices manufactured was limited and did not contain an overall engineering drawing. Some of the components (i.e., the laser) had specifications, but not all of the components related to the device and its operation. Checkmarks were used to record test results instead of the numerical test result.
6. Failure of the DMR for each device type to include or refer to the location of the device specifications, including software specifications, as required by 21 CFR 820.181 (a). For example, there was no documentation of the software specifications and testing of the software user interface and control program. The device has an embedded software program that controls the time elements of the laser and treatments. When the protocol and time treatment duration is selected, the software controls how long the laser is on and the total time, which varies from 5 to 20 minutes.
The embedded software program was developed by the laser (resonator) manufacturer, (b)(4) Although the overall requirements for the software program were communicated between (b)(4), these requirements were not formalized .
Your firm's response should be sent to Anastacia M. Bilek, U.S. Food and Drug Administration Division Director, DOE-A, OC, 1 0903 New Hampshire Ave., Building 66, Room 3512, Silver Spring, Maryland 20993. Refer to the Unique Identification Number (CMS case# 192032) when replying. If you have any questions about the contents of this letter, please contact: Ms. Bilek at (301) 796-5770 or fax at (301) 847-8137.
Steven D. Silverman
Office of Compliance
Center for Devices and