# K083008: Coolskin

- Pathway: 510(k) (Abbreviated)
- Applicant: Elbio Co., Ltd.
- Decided: Jun 10, 2009 after 245 days
- Product code: ILO (Pack, Hot Or Cold, Water Circulating)
- Device class: 2
- Regulation: 21 CFR 890.5720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K963094 (1996). 37 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060395: Cryo, Model V6.0, Zimmer Elektromedizin GmbH (2006) Summary page 1.

## Most influential descendants
- K213294: Dermal Cooling System (2022), 1 descendant of its own
- K253261: Apollo Quattro (APQ-10M) (2026), 0 descendants of its own

## Indications for use
This device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief of injections.

Source page: https://510kreport.com/device/K083008
Methodology: https://510kreport.com/methodology