# DEN090002: Zeltiq Aesthetics Dermal Cooling Device

- Pathway: De Novo (Post-NSE)
- Applicant: Zeltiq Aesthetics
- Decided: Aug 24, 2010 after 315 days
- Product code: OOK (Dermal Cooling Pack/Vacuum/Massager)
- Device class: 2
- Regulation: 21 CFR 878.4340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
32 later devices descend from it; 4 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K120023: Zeltiq Coolsculpting (2012), 31 descendants of its own
- K133212: Zeltiq Coolsculpting System (2014), 30 descendants of its own
- K142491: ZEL TIQ CoolSculpting System (2015), 27 descendants of its own
- K151179: ZELTIQ CoolSculpting System (2015), 26 descendants of its own
- K150724: SculpSure (2015), 21 descendants of its own

Source page: https://510kreport.com/device/DEN090002
Methodology: https://510kreport.com/methodology