
Hgm Medical Laser Systems, Inc.
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PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 is an FDA 510(k)-cleared medical device (K911104) manufactured by Hgm Medical Laser Systems, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 10, 1991. Regulation: 8.