Dermal Cooling System
FDA 510(k) clearance K213294 · decided 2022-11-10
Clearance details
- K-number
- K213294
- Device name
- Dermal Cooling System
- Applicant
- R2 Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2021-10-01
- Decision date
- 2022-11-10
- Days to decision
- 405 days
- Clearance type
- Traditional
- Product code
- QPZ
- Device class
- 2
- Regulation number
- 878.4340
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Ramon, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| R2 Dermabrasion Tip (for Dermal Cooling System) (K203006) | R2 Technologies, Inc. | 2021-08-05 |
Recalls involving this device
No recalls on record reference this clearance.