Clearance Summary
MODEL MC 1100 SURGICAL YAG LASER received FDA 510(k) clearance under submission number K903943, sponsored by Klinger Micro-Controle Group. 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 1990-11-21.
- Submission: K903943
- Applicant / Sponsor: Klinger Micro-Controle Group
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 1990-11-21
Classification & Regulation
This clearance is catalogued under FDA product code GEX and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.