Clearance Summary
SAPPHIRE ST PORTABLE DIODE LASER received FDA 510(k) clearance under submission number K103667, sponsored by Den-Mat Holdings, LLC. 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 2010-12-29.
- Submission: K103667
- Applicant / Sponsor: Den-Mat Holdings, LLC
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2010-12-29
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.