FDA WARNING_LETTER - Cutera Inc. - July 09, 2012

The FDA issued a Warning Letter to Cutera, Inc. on July 9, 2012, regarding their GenesisPlus Laser System. The FDA's Office of Compliance reviewed Cutera's website and found the firm was marketing the GenesisPlus with uncleared indications and had made significant technological changes to the device without proper notification.

The GenesisPlus (K103626) was cleared for specific dermatological and podiatric uses, including temporary increase of clear nail in onychomycosis patients. However, Cutera's website promoted the device for "skin rejuvenation," "collagen stimulation," and "treatment of nail infection (onychomycosis)," which are major changes in intended use and could affect safety and effectiveness. These new indications render the device adulterated under section 501(f)(1)(B) and misbranded under section 502(o) of the Federal Food, Drug, and Cosmetic Act, as no premarket approval (PMA) or 510(k) notification was submitted.

Additionally, the FDA found that Cutera modified the treatment spot size for podiatry use from the cleared 1 mm to 1.5 and 5 mm, a significant technological change. This modification, without required 510(k) notification, further misbrands the device under section 502(o).

Cutera, Inc. is required to immediately cease dissemination of the described promotional