Medical Device Manufacturer · US , Salt Lake City , UT

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

2 submissions · 2 cleared · Since 1994

Recent clearances: ORBSHOT KERATOMETER, ORBSCAN(TM) KERATOMETER

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

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

2 devices

1-2 of 2

Cleared Mar 26, 1997

ORBSHOT KERATOMETER

Ophthalmic · 110d

Cleared Jul 06, 1994

ORBSCAN(TM) KERATOMETER

Ophthalmic · 141d

Data Source

Sourced from the FDA 510(k) public files . 176,583 total devices indexed.

Last updated: Sep 06, 2026