# K161296: Cool Renewal

- Pathway: 510(k) (Traditional)
- Applicant: Cool Renewal, LLC
- Decided: Jul 6, 2016 after 58 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: 2 generations back to K881349 (1988). 4 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130995: Nuance Cryo-Freeze Spray or Cryo-in-a-Can or Vandolay Freeze Spray, Nuance Medical, LLC (2013) Summary page 4.

## Most influential descendants
- K190747: Claritag (2019), 9 descendants of its own
- K211099: Freeze’n Clear Skin Clinic Warts & Tags (2022), 8 descendants of its own
- K242932: Skin Clinic Nitro Clear Wart Remover (2025), 1 descendant of its own
- K243487: CryoFreeze Wart and Skin Tag Remover (2025), 1 descendant of its own
- K240226: Pixie Skin Tag (2024), 1 descendant of its own

## Indications for use
1,1,1,2-tetrafluoroethane, Pentafluoroethane, and 1,1,1- trifluoroethane is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratosis, actinic keratosis, achrochordon (skin tags), molluscum contagiosum, age spots, dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyogenic granuloma.

Source page: https://510kreport.com/device/K161296
Methodology: https://510kreport.com/methodology