Medical Device Manufacturer · US , Santa Barbara , CA

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

3 submissions · 3 cleared · Since 2020

3

Total

3

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sientra, Inc. General & Plastic Surgery ✕

3 devices

1-3 of 3

Cleared Jun 08, 2023

AlloX2 Pro Tissue Expanders

General & Plastic Surgery · 525d

Cleared May 10, 2023

Sientra, inc. Portfinder

General & Plastic Surgery · 387d

Cleared Nov 16, 2020

Sientra OPUS Silicone Gel Breast Implant Sizer

General & Plastic Surgery · 243d

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 15, 2026