FDA WARNING_LETTER - Flawless Beauty and Skin - January 19, 2022

During an inspection from November 16, 2021, to January 19, 2022, the FDA determined that Flawless Beauty LLC, an initial importer, markets several products as unapproved and misbranded medical devices. These products include the Relumins Premium Derma Pen, Relumins Premium Derma Pen Plus, MESOpower pen and needle modules, Relumins Branded 35 and 80 needle Dermastampers, Relumins Branded 1200 needle Dermarollers (1.0 mm and 2.0 mm), and the Relumins Intense Glow Beauty Care Tool.

The FDA found these products adulterated under section 501(f)(1)(B) of the Act because they lack an approved premarket approval (PMA) application or an approved investigational device exemption. They are also misbranded under section 502(o) for not having the required 510(k) premarket notification. The firm's website claims for these products, such as penetration beyond the stratum corneum, treating scars, wrinkles, and stimulating tissues, indicate they are intended to affect the body's structure or function, classifying them as devices.

Furthermore, the firm failed to fulfill annual registration and device listing requirements for fiscal year 2022, making the listed devices misbranded under section 502(o) for being