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Skin Sheek marketed four medical devices (CLEAR, ERASE, LIFT, and SILK) without required FDA premarket approval or clearance, violating the Federal Food, Drug, and Cosmetic Act. The CLEAR device was found to be adulterated because the company lacked either an approved Premarket Approval (PMA) application or an Investigational Device Exemption (IDE), and was also misbranded for failing to submit the required premarket notification (510(k)). The FDA determined that Skin Sheek was marketing the CLEAR for unapproved intended uses beyond the scope of legally classified needle-type epilators, including treatment of telangiectasia and clogged pores, which exceeded the device's authorized indications.