Clearance Summary
THE PL-1064 LASER SYSTEM received FDA 510(k) clearance under submission number K120938, sponsored by Sheaumann Laser, Inc.. 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 2012-09-24.
- Submission: K120938
- Applicant / Sponsor: Sheaumann Laser, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2012-09-24
Classification & Regulation
This clearance is catalogued under FDA product code PDZ and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.