# K161480: R2 Dermal Cooling System

- Pathway: 510(k) (Traditional)
- Applicant: R2 Dermatology
- Decided: Oct 5, 2016 after 127 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: 9 generations back to K010991 (2001). 24 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110754: Cryopen Cryosurgical System, K102214, Cryopen, Inc. (2011) Summary page 4.
- K152133: IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE System, Galil Medical, Ltd. (2015) Summary page 4.

## Most influential descendants
- K171398: Dermal Cooling System (2017), 4 descendants of its own
- K201260: Dermal Cooling System (2020), 3 descendants of its own
- 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 R2 Dermal Cooling System is a cryosurgical instrument intended for use in dermatologic procedures for the removal of benign lesions of the skin.

Source page: https://510kreport.com/device/K161480
Methodology: https://510kreport.com/methodology