510(k) K850572

HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K by Hgm, Inc. — Product Code HQF

K850572 is an FDA 510(k) premarket notification submitted by Hgm, Inc. for the device "HGM, INC. MEDICAL LASER ENDOCOAGULATOR MODEL 8-K". The FDA issued a decision of Substantially Equivalent on April 23, 1985. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Hgm, Inc. has at least 10 other 510(k) clearances on record.