Subcon Manufacturing Corporation 12/16/13
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Chicago District|
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
December 16, 2013
VIA UPS NEXT DAY
Mr. Charles T. Walneck
President and Chief Executive Officer
Subcon Manufacturing Corporation
201 Berg Street
Algonquin, Illinois 60102
Dear Mr. Walneck:
United Stated Food and Drug Administration (FDA) investigators conducted an inspection of your firm, Subcon Manufacturing Corporation, located at 201 Berg Street in Algonquin, Illinois from January 10, 2012 through January 31, 2012. The investigators determined that Subcon Manufacturing Corporation functions as a contract manufacturer and specification developer of light emitting diode (LED) products, including skincare systems and teeth whitening systems. These products include Revitalight Skin Care Systems (Models ST-747, 508 and SSE-1000) and the Evado (Model 1029) skincare system. These products are devices within the meaning of Section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. § 321(h)], 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.
FDA has reviewed your firm’s User Manual for the Evado Model 1029 and its website http://subconmrg.com and determined that the Evado Model 1029 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 described and marketed. The device 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 with major changes or modifications to the intended use without submitting a new premarket notification to FDA as required by Section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii).
Specifically, on February 25, 2011, the 510(k) for Revitalight Skin Care System, (b)(4), was transferred from the original applicant, Skincare Technology, Inc., to your firm along with the associated patents. FDA cleared 510(k), (b)(4), on June 27, 2005, for prescription use to provide LED light to the body (large and small pulsators) and facial massage (large pulsators). In addition, the following indications were given for each specific pulsator:
- “indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris” (Blue)
- “indicated to provide topical heating to promote increased blood flow, for temporary relaxation of muscle and relief of pain” (Amber)
- “indicated to provide topical heating to promote increased blood flow, for temporary relaxation of muscle and relief of pain” (Red)
However, your firm’s promotion of the device provides evidence that the device is intended for other indications,which would constitute a major change or modification to its intended use, for which your firm lacks clearance or approval. Examples include:
“The Model 1029 is an FDA cleared and CE marked medical device. Shown to be effective on:
- Chronic Pain (CTS, Arthritis, and more)
- Post-Operative Pain
- Musculoskeletal Pain (Back Pain, Neck Pain, and more)
- Joint Inflammation
- General Inflammation and Swelling
- Sinus Pain Relief
- Promote blood flow post exercise to reduce delayed onset muscle soreness
- Acne Vulgaris by singlet oxygen production resulting in bacterial destruction
- Dermatological Conditions (Rosacea, Hyper Pigmentation, Anti-Aging, and more)
- Promotes the healing of wounds by increasing cellular metabolism”
These indications represent major change in the intended use of the device. Additionally, specific indications for pain relief may require clinical data under a new premarket submission.
Our review of the Revitalight Skin Care System Model SSE-1000 (Model SSE-1000) User Manual determined that the Model SSE-1000 Skin Care 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 (IDE) under Section 520(g) of the Act, 21 U.S.C. § 360j(g). The Model SSE-1000 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 in that a notice or other information respecting the modification to the device was not provided to the FDA as required by Section 510(k), 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(i). Specifically, you have modified the RevitalightSkin Care System by combining red and blue light for treating acne. Examples include, but are not limited to:
- The Model SSE-1000 utilizes Light Emitting Diodes to provide light to the body. Generally indicated to: treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris (Blue, Blue + Red light)
Using a combination light system to treat acne would require that your firm submit a premarket notification.
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, as required by 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.
Our office requests that Subcon Manufacturing Corporation immediately cease activities that result in the misbranding or adulteration of the Evado Model 1029 and Revitalight Skin Care System, such as the commercial distribution of the device for the uses discussed above.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
Please notify this office in writing within fifteen working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Carrie Ann Plucinski, Compliance Officer, Food and Drug Administration, 550 W. Jackson Blvd., 15th floor, Chicago, IL 60661. Refer to the Unique Identification Number (CMS Case # 375498) when replying. If you have any questions about the content of this letter, please contact Ms. Plucinski at 312-596-4224.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA.
Scott J. MacIntire