Clearance Summary
LASERCOMP MODEL: 10 STAR 10 received FDA 510(k) clearance under submission number K885170, sponsored by Laser-West. 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 1989-06-05.
- Submission: K885170
- Applicant / Sponsor: Laser-West
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 1989-06-05
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.