Clearance Summary
PHOTCOAGULATOR KR-568 LASER SPECTRUM ELITE K1 received FDA 510(k) clearance under submission number K911104, sponsored by Hgm Medical Laser Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1991-06-11.
- Submission: K911104
- Applicant / Sponsor: Hgm Medical Laser Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5090
- Decision date: 1991-06-11
Classification & Regulation
This clearance is catalogued under FDA product code FEX and 21 CFR 876.5090, within the Gastroenterology, Urology review panel as a Class I device.