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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Veinwave Ltd 5/12/14

   

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 

 

May 12, 2014
 
WARNING LETTER
 
 
Via United Parcel Service
 
Laurence Mark Newman
Director
Newlands Clinical Trials Ltd.
Veinwave Ltd.
T/A Medical Innovations
Newlands Medical Centre
315 Chorley New Road
Bolton, United Kingdom BL1 5BP
 
Re: Veinwave & Thermavein (aka VBeauty)
CTS GEN1100039
 
Dear Mr. Newman:
 
The United States Food and Drug Administration (FDA) has learned that your firm is marketing Veinwave and Thermavein (aka VBeauty) 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 affect the structure or any function of the body.
 
The FDA has reviewed www.medinnovations.com and www.veinwave.com and determined that the Veinwave 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, the Veinwave was cleared under K083352 with the following indications: “The Veinwave/TC3000 system is intended for epilation and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation.” However, your firm’s websites reveal that the device is being promoted for facial red veins and rosacea, which would constitute a major change or modification to its intended use, for which your firm’s device lacks clearance or approval. Examples include:
 
The website, www.medinnovations.com/products/Veinwave/, displays promotional material that contains statements such as, “It treats red spots and all spider veins on the legs and the feet as well as troublesome facial red veins and rosacea.”  This page also displays pre-op and post-op photos of a human nose, which further suggests the product’s intended use for facial vascular conditions.
 
The website, www.veinwave.com, displays promotional videos that illustrate the use of Veinwave to physicians and patients and testimonials about the product’s use for treatment of rosacea and facial veins. 
 
The FDA also reviewed www.medinnovations.com and determined that the Thermavein (aka VBeauty) 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 Thermavein is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction this device into interstate commerce for commercial distribution, intended for a use different from the intended use of a legally marketed device in the generic type of device described at 21 CFR 878.5350 Epilator, High Frequency, Needle-Type, without submitting a 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). 
 
Devices classified under 21 CFR878.5350 Epilator, High Frequency, Needle-Type are exempt from premarket notification unless they exceed the limitations on exemption at 21 CFR 878.9(a). However, there is evidence that the Thermavein (aka VBeauty) is intended for uses that are different from those of legally marketed devices classified under 21 CFR878.5350 Epilator, High Frequency, Needle-Type.  Generic devices of this type are intended for hair removal. However, your firm is marketing Thermavein for different intended uses, namely facial and spider veins, red spot, rosacea and other facial vascular conditions for which your device lacks clearance or approval. Examples include:
 
The website, www.medinnovations.com/products/vbeauty, displays promotional materials that include statements of safety and effectiveness for non-cleared uses such as:
 
·         “It is the most advanced and safe treatment for the removal of facial and spider veins.”
 
·         “Thermavein treats red spot, rosacea, and most facial red veins, including those intra-nasal veins which have previously been untreatable.”
 
The website, www.medinnovations.com/products, also displays photos and links to promotional videos that illustrate uses for Thermavein, which were not cleared by FDA such as rosacea and other facial vascular conditions.   
 
Because there is evidence that Thermavein is intended for uses that are different from those of legally marketed devices classified under 21 CFR 878.5350, it exceeds the limitations described in 21 CFR 878.9(a) and is not exempt from 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.  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 Newlands Clinical Trials Ltd., Veinwave Ltd., and Medical Innovations Ltd. immediately cease activities that result in the misbranding or adulteration of the Veinwave and Thermavein (aka VBeauty), 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. 
 
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# 421485 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.
 
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 :
 
Debra Ferland (US Agent)
Qserve Group US, Inc.
183 Black North Rd
Acworth, NH 03601
 
Newlands Clinical Trials Ltd
Veinwave Ltd
Newlands Medical Centre
315 Chorley New Rd
Bolton, UK BL1 5BP
 
Medical Innovations Ltd
Newlands Medical Centre
315 Chorley New Rd
Boltoin, UK BL1 5BP
 
Veinwave Ltd
311 North Robertson Blvd, Suite 630
Beverly Hills, CA 90211