510(k) K123542

PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER by Topcon Medical Laser Systems, Inc. — Product Code HQF

K123542 is an FDA 510(k) premarket notification submitted by Topcon Medical Laser Systems, Inc. for the device "PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER". The FDA issued a decision of Substantially Equivalent on May 15, 2013. 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.