Medical Device Manufacturer · US , Sturbridge , MA

Optim, LLC - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2012

Total

Cleared

Denied

Optim, LLC has 4 FDA 510(k) cleared medical devices. Based in Sturbridge, US.

Latest FDA clearance: May 2026. Active since 2012. Primary specialty: Gastroenterology & Urology.

Browse the FDA 510(k) cleared devices submitted by Optim, LLC Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Delphi Medical Device Consulting, Inc. as regulatory consultant.

Optim, LLC is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Optim, LLC

4 devices

1-4 of 4

Data Source

Sourced from the FDA 510(k) public files . 175,450 total devices indexed.

Last updated: Jun 05, 2026