Claire OCT System is an AI-enabled medical device from Perimeter Medical Imaging Ai, Inc. that the U.S. FDA approved through PMA P250008 on March 3, 2026. Its lead review panel is General and Plastic Surgery and its primary product code is SHH.
See also all FDA AI clearances in 2026.
Key facts
| Submission number | P250008 |
|---|---|
| Pathway | PMA |
| Date of final decision | |
| Company (FDA list) | Perimeter Medical Imaging Ai, Inc. |
| Lead review panel | General and Plastic Surgery |
| Primary product code | SHH |
Source: FDA AI-Enabled Medical Devices list. No matching openFDA record was found for this submission yet.
What this means
Premarket Approval (PMA) is FDA's most stringent pathway, used for Class III devices. It requires valid scientific evidence of safety and effectiveness. Claire OCT System went through this pathway (P250008).
Product code SHH covers 1 device on the FDA AI list. By decision date, this device is #1 of 1 under that code. Perimeter Medical Imaging Ai, Inc. has 2 AI-enabled devices on the list, and the General and Plastic Surgery panel accounts for 9 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.