Clearance Summary
CANDELA 10MM CIRCULAR SPOT LASER HANDPIECE received FDA 510(k) clearance under submission number K950661, sponsored by Candela Laser Corp.. 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 1995-03-10.
- Submission: K950661
- Applicant / Sponsor: Candela Laser Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 1995-03-10
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.