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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Clinical Lasers, Inc. 11/14/13

  

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 

 

WARNING LETTER
 
November 14, 2013
 
Stephen Soos
President & CEO
Clinical Lasers
1521 Concord Pike, #303
Wilmington Delaware, 19803
 
Re: Sigma Lumilite i10, Sigma D-Lase, Sigma KD-Lase Sigma KD-Lase-X, Omnilase1, Long Pulse Nd, Er, Q-Switched Nd, Standard Cooling IPL Big Spot IPL lasers, OmniDep i810, OmniPhotonix, OmniYag, QuadWave, OmniFace, OmniSculpt Thermal RF, Hanya 2, NeXus, LumiSlim x820 Duolite, LumiSlim X 10201 Duolite, LumiSlim Titan, Sigma iShape body contour & skin uplift system
 
Refer to CPT1300338
 
Dear Mr. Soos:
 
The United States Food and Drug Administration (FDA) has reviewed your firm’s website, www.clinicallasers.com, and learned that your firm is marketing Sigma Lumilite i10, Sigma D-Lase, Sigma KD-Lase, Sigma KD-Lase-X, Omnilase1, Long Pulse Nd, Er, and OmniDep i810 intended for hair removal. In addition, your firm is marketing OmniPhotonix, OmniYag QuadWave, OmniFace, OmniSculpt Thermal RF, Hanya 2, NeXus, LumiSlim x820 Duolite, LumiSlim X 10201 Duolite, LumiSlim Titan, Q-Switched Nd, Standard Cooling IPL, Big Spot IPL lasers, and the Sigma iShape body contour & skin uplift system. These products are marketed in the United States without 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.
 
A view of our records reveals that your firm has not obtained marketing clearance or approval before offering these devices for sale.  Therefore these 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). The 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).807.81(b). 
 
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 Clinical Lasers immediately cease activities that result in the misbranding or adulteration of these devices, 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 (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.
 
Your firm’s response should be sent to:
 
Food and Drug Administration
Center for Devices and Radiological Health
Office of Compliance
Field Operations Branch
White Oak Building 66, Rm 2609
10903 New Hampshire Ave.
Silver Spring, MD 20993
 
Refer to the identification number CPT1300338 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: Ms. LaShanda Long at (301)796-5465 or (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