# K171398: Dermal Cooling System

- Pathway: 510(k) (Traditional)
- Applicant: R2 Dermatology,Inc
- Decided: Jul 6, 2017 after 55 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: 10 generations back to K010991 (2001). 25 ancestors in all.
4 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)
- K161480: R2 Dermal Cooling System, R2 Dermatology (2016) Summary page 4.

## Most influential descendants
- 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 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/K171398
Methodology: https://510kreport.com/methodology