Clearance Summary
SOPRANO HAIR REMOVAL DIODE LASER received FDA 510(k) clearance under submission number K052874, sponsored by Msq (M2) , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2005-11-22.
- Submission: K052874
- Applicant / Sponsor: Msq (M2) , Ltd.
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2005-11-22
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.