Clearance Summary
POLAR WAND received FDA 510(k) clearance under submission number K021387, sponsored by Chek-Med Systems. 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 2002-07-31.
- Submission: K021387
- Applicant / Sponsor: Chek-Med Systems
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4350
- Decision date: 2002-07-31
Classification & Regulation
This clearance is catalogued under FDA product code GEH and 21 CFR 878.4350, within the General, Plastic Surgery review panel as a Class II device.