FDA WARNING_LETTER - Cynergy, LLC / Dermaroller Gmbh

The FDA issued a Warning Letter to Cynergy, LLC for marketing Dermarollers without marketing clearance or approval in the U.S. The FDA determined that products like Medical Dermaroller, Derma Stamp, eDermaStamp, Home Dermaroller, and Dermaroller Beauty Mouse are devices under section 201(h) of the Act. A review of the firm's website revealed numerous claims for these devices, including triggering angiogenesis and collagenesis, treating acne/burn scars, reducing wrinkles, and enhancing skincare delivery. Although registered as manual surgical instruments (21 CFR 878.4800), the stated intended uses and the incorporation of needles with specific penetration depths (e.g., 0.5mm-2.5mm) and electrical-driven technology exceed the limitations described in 21 CFR 878.9(a) and (b). Consequently, the dermarollers are not exempt from premarket notification. This renders the devices adulterated under section 501(f)(1)(B) for lacking an approved PMA or IDE, and misbranded under section 502(o) for failure to submit a 510(k) premarket notification. Cynergy is required to immediately cease distribution, sale, and promotion of these devices and submit a written response within fifteen working days outlining corrective actions. Failure to comply may lead to regulatory actions, including seizure, injunction, civil money penalties, and refusal of admission for imported products.