meddevicedb.com FDA Device Reference

Freeze’n Clear Skin Clinic Warts & Tags

K211099 Class II Traditional
Decision Date
2022-06-17
Sponsor / Applicant
Cryoconcepts LP

Technical Specification

510(k) Submission ID K211099
Product Code GEH
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4350
Decision Date 2022-06-17
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Freeze’n Clear Skin Clinic Warts & Tags received FDA 510(k) clearance under submission number K211099, sponsored by Cryoconcepts LP. 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 2022-06-17.

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.