Clearance Summary
DCL8 ENHANCED PULSED ND:YAG LASER SYSTEM received FDA 510(k) clearance under submission number K960086, sponsored by Slt-J , Ltd.. 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 1996-06-03.
- Submission: K960086
- Applicant / Sponsor: Slt-J , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 1996-06-03
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.