# OOK: Dermal Cooling Pack/Vacuum/Massager

- Device class: 2; regulation: 21 CFR 878.4340; FDA's rule: 510(k) required
- FDA decisions: 14
- 510(k) review time 2021–2025: median 184 days (middle half 127–240)
- Recalls: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2012: 1
- 2014: 1
- 2015: 2
- 2016: 2
- 2017: 2
- 2018: 1
- 2019: 1
- 2020: 1
- 2021: 1
- 2024: 1

## Most-cited predicates
- DEN090002: Zeltiq Aesthetics Dermal Cooling Device (2010), cited by 4
- K133212: Zeltiq Coolsculpting System (2014), cited by 4
- K120023: Zeltiq Coolsculpting (2012), cited by 3
- K162050: ZELTIQ CoolSculpting System (2016), cited by 3
- K172144: CoolSculpting System (2017), cited by 2
- K151179: ZELTIQ CoolSculpting System (2015), cited by 2
- K160259: ZELTIQ CoolSculpting System (2016), cited by 1
- K183514: ZELTIQ CoolSculpting System (2019), cited by 1
- K142491: ZEL TIQ CoolSculpting System (2015), cited by 1
- K212707: CoolSculpting Elite System (2021), cited by 1

Source page: https://510kreport.com/product-code/OOK
Data by year (CSV): https://510kreport.com/product-code/OOK.csv