510(k) K180402

PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar by Topcon Medical Laser Systems, Inc. — Product Code HQF

K180402 is an FDA 510(k) premarket notification submitted by Topcon Medical Laser Systems, Inc. for the device "PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar". The FDA issued a decision of Substantially Equivalent on May 25, 2018. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Topcon Medical Laser Systems, Inc. has at least 5 other 510(k) clearances on record.