Clearance Summary
SPECTRA-SP CO2 LASER SYSTEM received FDA 510(k) clearance under submission number K050254, sponsored by Max Engineering , 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 2005-04-15.
- Submission: K050254
- Applicant / Sponsor: Max Engineering , Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2005-04-15
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.