K201260 is an FDA 510(k) clearance for the Dermal Cooling System. This device is classified as a Unit, Cryosurgical, Accessories (Class II - Special Controls, product code GEH).
Submitted by R2 Technologies, Inc. (San Ramon, US). The FDA issued a Cleared decision on September 24, 2020, 136 days after receiving the submission on May 11, 2020.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4350.
| 510(k) Number | K201260 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 11, 2020 |
| Decision Date | September 24, 2020 |
| Days to Decision | 136 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 |