Clearance Summary
MDLS 4000/4900/6000/8000/8900/LUXUS 60/100 ND:YAG received FDA 510(k) clearance under submission number K903444, sponsored by Heraeus Lasersonics, Inc.. 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 1990-10-11.
- Submission: K903444
- Applicant / Sponsor: Heraeus Lasersonics, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 1990-10-11
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.