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Cutera, Inc. was cited for marketing the Juliet MCL 31 Dermablate System without required premarket approval or an approved investigational device exemption, making the device adulterated under FDA regulations. The company promoted the device for treating vaginal atrophy, vaginal relaxation syndrome, and genitourinary syndrome of menopause—indications that constituted major modifications to the cleared intended use without submitting a new 510(k) premarket notification as required by law. This violation rendered the device misbranded for commercial distribution. The warning followed Cutera's inadequate response to FDA's initial November 2022 warning letter addressing these same compliance failures.