# K183514: ZELTIQ CoolSculpting System

- Pathway: 510(k) (Special)
- Applicant: Zeltiq Aesthetics, Inc.
- Decided: Jan 14, 2019 after 27 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K193566: ZELTIQ CoolSculpting System (2020), 2 descendants of its own
- K212707: CoolSculpting Elite System (2021), 1 descendant of its own
- K233732: CoolSculpting Elite System (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K183514
Methodology: https://510kreport.com/methodology