510(k) K911104

PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 by Hgm Medical Laser Systems, Inc. — Product Code FEX

K911104 is an FDA 510(k) premarket notification submitted by Hgm Medical Laser Systems, Inc. for the device "PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1". The FDA issued a decision of Substantially Equivalent on June 11, 1991. The device falls under product code FEX (Instrument, Catheter, Punch), a Class I device regulated under 21 CFR 876.5090. Hgm Medical Laser Systems, Inc. has at least 10 other 510(k) clearances on record.