The following data is part of a premarket notification filed by R2 Technologies, Inc. with the FDA for Dermal Cooling System.
| Device ID | K213294 |
| 510k Number | K213294 |
| Device Name: | Dermal Cooling System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | R2 Technologies, Inc. 2603 Camino Ramon, Suite 200 San Ramon, CA 94583 |
| Contact | Ragan Reppond |
| Correspondent | Tarhan Kayihan R2 Technologies, Inc. 2603 Camino Ramon, Suite 200 San Ramon, CA 94583 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-01 |
| Decision Date | 2022-11-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850019947991 | K213294 | 000 |