# K213294: Dermal Cooling System

- Pathway: 510(k) (Traditional)
- Applicant: R2 Technologies, Inc.
- Decided: Nov 10, 2022 after 405 days
- Product code: QPZ (Contact Cooling For Skin Lesion Pain Relief)
- Device class: 2
- Regulation: 21 CFR 878.4340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K010991 (2001). 71 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203006: R2 Dermabrasion Tip (for Dermal Cooling System), R2 Technologies, Inc. (2021) Summary page 4.
- K083008: Coolskin, Elbio Co., Ltd. (2009) Summary page 4.

## Most influential descendants
- K253261: Apollo Quattro (APQ-10M) (2026), 0 descendants of its own

## Indications for use
The Dermal Cooling System is a cryosurgical instrument intended 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. The Dermal Cooling System is further indicated to minimize pain, inflammation, and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief of injections. When the Dermal Cooling System is used with the R2 Dermabrasion Tips, the intended use includes general dermabrasion, scar revision, acne scar revision, and tattoo removal. The Dermal Cooling System is intended to be used by trained healthcare professionals.

Source page: https://510kreport.com/device/K213294
Methodology: https://510kreport.com/methodology