Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K201260
Dermal Cooling System · R2 Technologies, Inc. · decided 2020-09-24 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Dermal Cooling System | M1-SC-FR2-100-0 | R2 Technologies, Inc. | GEH MLY | 00850019947533 |
| Dermal Cooling System | HP-005 | R2 Technologies, Inc. | GEH MLY | 00850019947014 |
| Dermal Cooling System | HP-002 | R2 Technologies, Inc. | GEH MLY | 00850019947045 |
| Dermal Cooling System | C2-001 | R2 Technologies, Inc. | GEH MLY | 00850019947007 |
| Dermal Cooling System | M1-SC-FR1-100-1 | R2 Technologies, Inc. | GEH MLY | 00850019947182 |