The following data is part of a premarket notification filed by R2 Technologies, Inc. with the FDA for R2 Dermabrasion Tip (for Dermal Cooling System).
| Device ID | K203006 |
| 510k Number | K203006 |
| Device Name: | R2 Dermabrasion Tip (for Dermal Cooling System) |
| Classification | Contact Cooling For Skin Lesion Pain Relief |
| Applicant | R2 Technologies, Inc. 2603 Camino Ramon, Suite 200 San Ramon, CA 94583 |
| Contact | Ragan Reppond |
| Correspondent | Ragan Reppond R2 Technologies, Inc. 2603 Camino Ramon, Suite 200 San Ramon, CA 94583 |
| Product Code | QPZ |
| CFR Regulation Number | 878.4340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-01 |
| Decision Date | 2021-08-05 |