Clearance Summary
CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980 received FDA 510(k) clearance under submission number K082263, sponsored by Biolitec, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2008-10-24.
- Submission: K082263
- Applicant / Sponsor: Biolitec, Inc.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2008-10-24
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.