Clearance Summary
MODIFIED COMBOLASER 5050 & NEW MODEL 5050 VER. 33 received FDA 510(k) clearance under submission number K901638, sponsored by Lasermatic, 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 1990-06-27.
- Submission: K901638
- Applicant / Sponsor: Lasermatic, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 1990-06-27
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.