K213294 is an FDA 510(k) clearance for the Dermal Cooling System. This device is classified as a Contact Cooling For Skin Lesion Pain Relief (Class II - Special Controls, product code QPZ).
Submitted by R2 Technologies, Inc. (San Ramon, US). The FDA issued a Cleared decision on November 10, 2022, 405 days after receiving the submission on October 1, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4340. 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..
| 510(k) Number | K213294 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2021 |
| Decision Date | November 10, 2022 |
| Days to Decision | 405 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | QPZ - Contact Cooling For Skin Lesion Pain Relief |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4340 |
| 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. |