510(k) K904699

COMPAC(TM) DIODE LASERS by Hgm Medical Laser Systems, Inc. — Product Code HQF

K904699 is an FDA 510(k) premarket notification submitted by Hgm Medical Laser Systems, Inc. for the device "COMPAC(TM) DIODE LASERS". The FDA issued a decision of Substantially Equivalent on April 25, 1991. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Hgm Medical Laser Systems, Inc. has at least 10 other 510(k) clearances on record.