Clearance Summary
Skin Clinic Freeze Point for Warts and Skin Tags received FDA 510(k) clearance under submission number K251493, sponsored by Cryoconcepts LP. 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 2025-05-22.
- Submission: K251493
- Applicant / Sponsor: Cryoconcepts LP
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4350
- Decision date: 2025-05-22
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.