510(k) K092621

PASCAL STREAMLINE PHOTOCOAGULATOR by Topcon Medical Laser Systems, Inc. — Product Code HQF

K092621 is an FDA 510(k) premarket notification submitted by Topcon Medical Laser Systems, Inc. for the device "PASCAL STREAMLINE PHOTOCOAGULATOR". The FDA issued a decision of Substantially Equivalent on September 25, 2009. 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.