K250742 is an FDA 510(k) clearance for the Focused Cryotherapy System, a Unit, Cryosurgical, Accessories (Class II — Special Controls, product code GEH), submitted by Focused Cryo, Inc. (Marietta, US). The FDA issued a Cleared decision on December 9, 2025, 273 days after receiving the submission on March 11, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K250742 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 11, 2025 |
| Decision Date | December 09, 2025 |
| Days to Decision | 273 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 |