Inspections, Compliance, Enforcement, and Criminal Investigations

Advanced Photonic Systems, LLC 1/15/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

January 15, 2014
 
 
WARNING LETTER
 
VIA UNITED PARCEL SERVICE
 
Terry J. Ward
General Manager
Advanced Photonic Systems, Inc.
9029 Tuscan Valley Place
Orlando, Florida 32825
 
Re: UltraSlim and Luxurian 150 Lighting Systems
Refer to CMS # 415536
 
Dear Mr. Ward:
 
The United States Food and Drug Administration (FDA) has learned that your firm is marketing the UltraSlim and Luxurian 150 lighting systems in the United States without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
 
Under section 201(h) of 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.
 
During an inspection of your firm, located in Orlando, Florida, on March 27, 2013, FDA investigators reviewed information for the UltraSlim and Luxurian 150 lighting systems. Additionally, FDA  has reviewed your firm’s website (www.advancedphotonicsystems.com), including the user manuals for the UltraSlim and Luxurian 150 lighting systems. A review of this information demonstrates that the UltraSlim and Luxurian 150 lighting systems are being marketed with the following indications, including but not limited to:
 
  • The UltraSlim program provides a non‐invasive solution to improve the appearance of fat deposits, cellulite, fine lines, wrinkles, skin tone, and blemishes. UltraSlim may also assist as part of a weight loss program.
  • The UltraSlim program combines detoxification, red light exposure, hydration, full‐body vibration, massage, Niacin, Milk Thistle, and the use of compression garments. Sensible diet and exercise are recommended, but not required.
  • UltraSlim and Luxurian red light technologies provide non-invasive solutions to improve the appearance of fat accumulations, cellulite, fine lines, wrinkles, skin tone, and blemishes.
 
A review of our records reveals that your firm has not received premarket clearance or approval to market these devices in the United States, which is a violation of the law. Therefore, the UltraSlim and Luxurian 150 lighting systems 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).  The UltraSlim and Luxurian 150 lighting systems 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 device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). 
 
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.
 
Our office requests that Advanced Photonic Systems immediately cease activities that result in the misbranding or adulteration of the UltraSlim and Luxurian 150 lighting systems, such as the commercial distribution of the device for the uses discussed above.
 
Your firm 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 FDA without further notice.  These actions include, but are not limited to, seizure, injunction, and 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 award of contracts. 
 
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 (which must address systemic problems) 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.
 
Your firm’s response should be sent to:
 
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Field Inspections Support Branch
White Oak Building 66, Rm 2609
10903 New Hampshire Ave.
Silver Spring, MD 20993
 
Refer to the identification number CMS # 415536 when replying. We remind you that only written communication is considered as official.  If you have any questions about the contents of this letter, please contact: LaShanda M. Long, Chief, Surveillance and Enforcement Branch I, Division of Premarket and Labeling Compliance, Office of Compliance, at (301) 796-5465 or via fax at (301) 847-8137.
 
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm.  It is your firm’s responsibility to ensure compliance with the applicable laws and regulations administered by FDA. 
 
Sincerely yours,
/S/ 
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
     Radiological Health
 
 
cc: Terry J. Ward
      General Manager
      Advanced Photonic Systems, LLC
      1980 N. Atlantic Avenue, Suite 930
      Cocoa Beach, Florida 32931

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