Clearance Summary
DERMASCAN LASER SURGICAL HANDPIECE received FDA 510(k) clearance under submission number K860083, sponsored by Medical Laser Research & Development 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 1986-08-07.
- Submission: K860083
- Applicant / Sponsor: Medical Laser Research & Development Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 1986-08-07
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.