Clearance Summary
Alexandrite and Nd:YAG Laser models CANLASE and TORLASE received FDA 510(k) clearance under submission number K222673, sponsored by Canadian Pioneer Medical Technology Corporation (Cpmt Laser). 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 2022-11-17.
- Submission: K222673
- Applicant / Sponsor: Canadian Pioneer Medical Technology Corporation (Cpmt Laser)
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 2022-11-17
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.