Clearance Summary
TRILASE 2940 ERBIUM LASER received FDA 510(k) clearance under submission number K954013, sponsored by Schwartz Electro-Optics, 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 1996-01-31.
- Submission: K954013
- Applicant / Sponsor: Schwartz Electro-Optics, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 1996-01-31
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.