FDA WARNING_LETTER - Cutera, Inc. - February 14, 2023

The FDA issued a Warning Letter to David H. Mowry of Cutera on February 8, 2023, following an evaluation of their corrective actions in response to a previous Warning Letter (CMS # 639552, November 10, 2022). The FDA determined that the Juliet MCL 31 Dermablate System is adulterated under section 501(f)(1)(B) of the Act because Cutera lacks an approved premarket approval (PMA) or investigational device exemption (IDE) for the device as marketed.

The device is also misbranded under section 502(o) of the Act, as Cutera introduced it into interstate commerce with major changes to its intended use without submitting a new premarket notification (510(k)). The device was cleared under K210634 for coagulation, vaporization, ablation, or cutting of soft tissue in various surgical fields, and for dermatological and skin resurfacing procedures. However, Cutera's website promotes the device for treating vaginal atrophy, vaginal relaxation syndrome, genitourinary syndrome of menopause, wound healing, and tissue remodeling, which are unapproved uses.

The adequacy of Cutera's response to the initial Warning Letter cannot be determined. While a "dear doctor" letter and comprehensive review of websites were completed, the comprehensive review of all marketing materials is still ongoing. The FDA requires an additional written