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# FDA Hits Cutera With Warning on Web Site Promo
- URL: https://www.fdaweb.com/fda-hits-cutera-with-warning-on-web-site-promo/
- Published: 2022-12-02T12:00:00.000Z
- Updated: 2026-09-14T18:08:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153314

FDA has issued Cutera a Warning Letter related to marketing material that appeared on a company owned Web site about gynecological indications, including vaginal rejuvenation, for a device designed and manufactured by a third party. The letter, which has yet to be publicly released, stems from a 2019 commitment the company says it made to the agency 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 U.S. Web site,” Cutera says. “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.”

Cutera says it has responded to the Warning Letter indicating that the Web site displaying the violative material was registered to Cutera, but hosted and managed by a non-U.S. third party on the company’s behalf, and it 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and is taking action to prevent any such recurrence,” the company says, adding that the site identified by the FDA is no longer active.

“Cutera intends to accelerate its full exit from this market segment in a manner that supports our customers while being fully compliant with FDA guidance,” the company says.