K253348 is an FDA 510(k) clearance for the TargetCool-e, a Unit, Cryosurgical, Accessories (Class II — Special Controls, product code GEH), submitted by Recensmedical, Inc. (Hwaseong-Si, KR). The FDA issued a Cleared decision on October 15, 2025, 15 days after receiving the submission on September 30, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K253348 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 30, 2025 |
| Decision Date | October 15, 2025 |
| Days to Decision | 15 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 |