510(k) K890787

O-020 LASER INDIRECT OPHTHALMOSCOPE by Hgm Medical Laser Systems, Inc. — Product Code HGF

K890787 is an FDA 510(k) premarket notification submitted by Hgm Medical Laser Systems, Inc. for the device "O-020 LASER INDIRECT OPHTHALMOSCOPE". The FDA issued a decision of Substantially Equivalent on March 24, 1989. The device falls under product code HGF (Source, Abortion Unit, Vacuum), a Class II device regulated under 21 CFR 884.5070. Hgm Medical Laser Systems, Inc. has at least 10 other 510(k) clearances on record.