Medical Device Manufacturer · US , Irvine , CA

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

2 submissions · 1 cleared · Since 1998

Recent clearances: OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450, REFRACTEC MCS-100

View 2 510(k) Devices ↓

2

Total

1

Cleared

0

Denied

FDA 510(k) Regulatory Record - Refractec, Inc. Ophthalmic ✕

2 devices

1-2 of 2

Cleared Mar 03, 2006

OPTIPOINT CORNEAL MARKER, MODEL VPT-OPT-450

Ophthalmic · 79d

Cleared Jul 22, 1998

REFRACTEC MCS-100

Ophthalmic · 162d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 08, 2026