K211099 is an FDA 510(k) clearance for the Freeze’n Clear Skin Clinic Warts & Tags. This device is classified as a Unit, Cryosurgical, Accessories (Class II - Special Controls, product code GEH).
Submitted by Cryoconcepts LP (Bethlehem, US). The FDA issued a Cleared decision on June 17, 2022, 430 days after receiving the submission on April 13, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K211099 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 2021 |
| Decision Date | June 17, 2022 |
| Days to Decision | 430 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | GEH - Unit, Cryosurgical, Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4350 |