FDA WARNING_LETTER - Skin Sheek - April 05, 2022

The FDA issued a Warning Letter to Skin Sheek for marketing four devices—CLEAR, ERASE, LIFT, and SILK—without required marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act. The FDA's review of the firm's website (www.skinsheek.com) revealed these devices are adulterated under section 501(f)(1)(B) and misbranded under section 502(o) of the Act due to the lack of approved Premarket Approval (PMA) or Investigational Device Exemption (IDE) applications, and failure to submit premarket notifications (510(k)).

Specifically, the CLEAR device, marketed as a "Needle-type epilator," is intended for uses beyond its classification exemption, including treating telangiectasia, acne, skin tags, and rosacea, thus requiring 510(k) clearance. The ERASE device, appearing to be an "Electrosurgical cutting and coagulation device," is marketed for microneedle RF energy delivery for skin tightening, scar treatment, and wrinkle reduction, which are not exempt from 510(k). The LIFT device, identified as a "Focused ultrasound stimulator system for aesthetic use," is marketed for lifting and tightening various body parts and cellulite reduction, also requiring 510(k). The SILK device, classified as a "Laser surgical instrument," is marketed for permanent