FDA WARNING_LETTER - Veinwave Ltd

The FDA issued a Warning Letter to Newlands Clinical Trials Ltd., Veinwave Ltd., and Medical Innovations Ltd. (collectively, "your firm") for marketing Veinwave and Thermavein (aka VBeauty) in the United States without marketing clearance or approval.

The Veinwave device is adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under section 502(o) for introducing the device with major changes to its intended use without submitting a new premarket notification (510(k)). Specifically, Veinwave was cleared for epilation and treatment of lower limb spider veins/telangiectasia, but promotional materials on www.medinnovations.com and www.veinwave.com show it being promoted for facial red veins and rosacea, constituting an uncleared major change in intended use.

The Thermavein (aka VBeauty) device is also adulterated under section 501(f)(1)(B) for lacking PMA or IDE approval. It is misbranded under section 502(o) because it is marketed for uses different from its legally marketed generic type (21 CFR 878.5350 Epilator, High Frequency, Needle-Type, intended for hair removal) without a 5