The following data is part of a premarket notification filed by R2 Dermatology with the FDA for R2 Dermal Cooling System.
| Device ID | K161480 |
| 510k Number | K161480 |
| Device Name: | R2 Dermal Cooling System |
| Classification | Unit, Cryosurgical, Accessories |
| Applicant | R2 Dermatology Bishop Ranch 3 2633 Camino Ramon San Ramon, CA 94583 |
| Contact | Kristine Tatsutani |
| Correspondent | Kristine Tatsutani R2 Dermatology Bishop Ranch 3 2633 Camino Ramon San Ramon, CA 94583 |
| Product Code | GEH |
| CFR Regulation Number | 878.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-31 |
| Decision Date | 2016-10-05 |
| Summary: | summary |