Medical Device Manufacturer · US , Pleasant Hill , CA

Topcon Medical Laser Systems, Inc. (Tmls) - FDA 510(k) Cleared Devices

2 submissions · 2 cleared · Since 2012

Recent clearances: PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System, PASCAL LASER INDIRECT OPHTHALMOSCOPE

View 2 510(k) Devices ↓

2

Total

2

Cleared

0

Denied

FDA 510(k) Regulatory Record - Topcon Medical Laser Systems, Inc. (Tmls) Ophthalmic ✕

1 devices

1-1 of 1

Cleared Nov 13, 2012

PASCAL LASER INDIRECT OPHTHALMOSCOPE

Ophthalmic · 43d

Data Source

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

Last updated: Sep 14, 2026