Cutera responds to FDA inquiry

Cutera "disclosed that it has provided a response to a recent FDA inquiry. In 2019, Cutera undertook remediation to remove all marketing materials related to gynecological indications, including vaginal rejuvenation, for a device designed and manufactured by a third party. This followed commitments that Cutera had made to the FDA to cease the promotion of MyJuliet for all vaginal rejuvenation and similar claims. As part of this remediation, Cutera requested that the 510(k) owner of MyJuliet, Asclepion, also stop promoting vaginal procedures on its US website. Moreover, Cutera offered all existing customers a replacement handpiece for skin revitalization along with a notification that vaginal procedures are not cleared by the FDA. The FDA, however, recently issued a Warning Letter to Cutera identifying a vestigial piece of marketing material that had escaped Cutera’s attention. Regrettably, a website that was registered to Cutera, but hosted and managed by a non-U.S. third party on Cutera’s behalf, was mistakenly not taken down in 2019. Cutera believes that this was an isolated oversight and is taking action to prevent any such recurrence. The site identified by the FDA is no longer active."