Cutera, Inc.

Warning LetterClosed

David H. Mowry CEO Cutera, Inc. 3240 Bayshore Blvd. Brisbane , CA 94005 United States (b)(6)@cutera.comFEI 3002900199Issued Feb 8, 2023Center for Devices and Radiological Health

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3002900199.

Letter Details

Firm: Cutera, Inc.
Location: David H. Mowry CEO Cutera, Inc. 3240 Bayshore Blvd. Brisbane , CA 94005 United States (b)(6)@cutera.com
FEI Number: 3002900199
Country: United States
Issue Date: February 08, 2023
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Closed
Closeout Letter: October 18, 2024

Summary

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.