Topcon Medical Laser Systems, Inc. - FDA 510(k) Cleared Devices
Recent clearances: PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar, PSLT for PASCAL Streamline, PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER
6
Total
6
Cleared
0
Denied
FDA 510(k) Regulatory Record - Topcon Medical Laser Systems, Inc. Ophthalmic ✕
5 devices
Cleared
May 25, 2018
PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar
Ophthalmic
100d
Cleared
CT
Nov 27, 2017
PSLT for PASCAL Streamline
Ophthalmic
189d
Cleared
May 15, 2013
PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER
Ophthalmic
177d
Cleared
Aug 11, 2011
PASCAL STREAMLINE 577 (WITH ACCESSORIES)
Ophthalmic
113d
Cleared
Sep 25, 2009
PASCAL STREAMLINE PHOTOCOAGULATOR
Ophthalmic
30d