After the July 30, 2017 announcement by the FDA regarding medical devices marketing themselves for vaginal rejuvenation, you may be wondering if vFit or vFit PLUS are included in the FDA’s investigation. The answer is “no”.
Joylux formally presented vFit/vFit PLUS to the FDA in early 2017 to determine appropriate device classification. Based on the FDA’s review of our claims and the technological characteristics of the devices, the FDA favorably designated vFit/vFit PLUS as a Low-Risk General Wellness Device.
Under the general wellness guidance document, terms such as rejuvenation, sexual function, wellness, pleasure and sensation, fall within this category. Medical devices, such as the ones listed in the FDA’s announcement, may only market themselves for the indications they are cleared for and according to the FDA, none of those identified have been cleared to market themselves with these claims.
vFit/vFit PLUS remain excellent solutions for intimate wellness. These are the first and only home-use devices using patented, light-based technology that is safe, effective, convenient and legally marketed.
Learn more here about our technology, study results, and doctor and customer testimonials.
Questions? Please email us at email@example.com or call 1.844.872.8578.