Medical Device Manufacturer · US , Brisbane , CA

Cutera, Inc. - FDA 510(k) Cleared Devices

31 submissions · 31 cleared · Since 2004

Total

Cleared

Denied

Cutera, Inc. is a medical device manufacturer specializing in aesthetic and surgical laser systems. The company operates with a manufacturing facility in Brisbane, US, and maintains a global presence across North America, Europe, and Australia.

Cutera has established a strong regulatory track record with the FDA. The company has received 31 FDA 510(k) clearances from 31 total submissions since its first clearance in 2004. The vast majority of its submissions focus on General & Plastic Surgery devices, reflecting the company's core expertise in this category. The most recent clearance in 2025 demonstrates continued regulatory activity and product innovation.

Cutera's cleared device portfolio includes laser systems and radiofrequency technologies designed for aesthetic and surgical applications. Notable product lines include the AviClear Laser System, enlighten III Laser System, truSculpt family of devices, and the xeo+ platform. These devices address diverse clinical needs within the General & Plastic Surgery space.

Explore Cutera's complete regulatory history, including specific device names, product codes, and individual clearance dates in the database.

FDA 510(k) Regulatory Record - Cutera, Inc.

31 devices

1-12 of 31