Clearance Summary
MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SA received FDA 510(k) clearance under submission number K991628, sponsored by Esc Medical Systems, 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 1999-08-09.
- Submission: K991628
- Applicant / Sponsor: Esc Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 1999-08-09
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.