# K201260: Dermal Cooling System

- Pathway: 510(k) (Traditional)
- Applicant: R2 Technologies, Inc.
- Decided: Sep 24, 2020 after 136 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K010991 (2001). 31 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171398: Dermal Cooling System, R2 Dermatology,Inc (2017) Summary page 4.
- K182392: Frozen C, B.M. Tech. Worldwide Co., Ltd. (2018) Summary page 4.

## Most influential descendants
- K203006: R2 Dermabrasion Tip (for Dermal Cooling System) (2021), 2 descendants of its own
- K213294: Dermal Cooling System (2022), 1 descendant of its own
- 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 intended to be used by trained healthcare professionals.

Source page: https://510kreport.com/device/K201260
Methodology: https://510kreport.com/methodology