QPZ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Contact Cooling For Skin Lesion Pain Relief
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4340
- Medical specialty
- General, Plastic Surgery
- FDA definition
- For use in dermatologic procedures for the removal of benign lesions of the skin and for use when cooling is intended for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures.
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| Record | Firm | Date |
|---|---|---|
| Dermal Cooling System (K213294) | R2 Technologies, Inc. | 2022-11-10 |
| R2 Dermabrasion Tip (for Dermal Cooling System) (K203006) | R2 Technologies, Inc. | 2021-08-05 |
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