Clearance Summary
ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY received FDA 510(k) clearance under submission number K875039, sponsored by Surgilase, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1988-04-13.
- Submission: K875039
- Applicant / Sponsor: Surgilase, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 1988-04-13
Classification & Regulation
This clearance is catalogued under FDA product code LNK and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.