510(k) K213294
K213294 is an FDA 510(k) premarket notification submitted by R2 Technologies, Inc. for the device "Dermal Cooling System". The FDA issued a decision of Substantially Equivalent on November 10, 2022. The device falls under product code QPZ (Contact Cooling For Skin Lesion Pain Relief), a Class II device regulated under 21 CFR 878.4340. R2 Technologies, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 10, 2022
- Date Received
- October 1, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Contact Cooling For Skin Lesion Pain Relief
- Device Class
- Class II
- Regulation Number
- 878.4340
- Review Panel
- SU
- Submission Type
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.