Advanced Photonic Systems, LLC 1/15/14

 

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:

 

 

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

 

 

cc: Terry J. Ward

      Advanced Photonic Systems, LLC