Clearance Summary
DOCTOR SMILE A-810 AND B-980 LASERS received FDA 510(k) clearance under submission number K091562, sponsored by Lambda Scientific Spa. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2009-09-08.
- Submission: K091562
- Applicant / Sponsor: Lambda Scientific Spa
- Clearance pathway: Abbreviated
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2009-09-08
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.