Clearance Summary
ADVANCED LASER MULTILINE SYSTEM, ALY received FDA 510(k) clearance under submission number K952796, sponsored by Advanced Laser Services 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 1995-09-18.
- Submission: K952796
- Applicant / Sponsor: Advanced Laser Services Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 1995-09-18
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.