The following data is part of a premarket notification filed by Cryoconcepts Lp with the FDA for Freeze’n Clear Skin Clinic Warts & Tags.
| Device ID | K211099 |
| 510k Number | K211099 |
| Device Name: | Freeze’n Clear Skin Clinic Warts & Tags |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | CryoConcepts LP 205 Webster St Bethlehem, PA 18015 |
| Contact | Sam Niedbala |
| Correspondent | Sam Niedbala CryoConcepts LP 205 Webster St Bethlehem, PA 18015 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-13 |
| Decision Date | 2022-06-17 |