Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
OOK — Predicate Candidate Screening
14 FDA 510(k) clearances under this product code; the 50 most recent screened below.
119 daysmedian FDA review time
296 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233732 | CoolSculpting Elite System | Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics | 2024-09-12 | 296 | 0 |
| K212707 | CoolSculpting Elite System | Zeltiq Aesthetics, Inc. | 2021-11-05 | 71 | 0 |
| K193566 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2020-01-21 | 29 | 1 |
| K183514 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2019-01-14 | 27 | 0 |
| K181740 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2018-08-29 | 58 | 0 |
| K172144 | CoolSculpting System | Zeltiq Aesthetics | 2017-11-01 | 107 | 0 |
| K171069 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2017-07-07 | 88 | 0 |
| K162050 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2016-11-21 | 119 | 0 |
| K160259 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2016-03-23 | 51 | 0 |
| K151179 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2015-09-22 | 141 | 0 |
| K142491 | ZEL TIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2015-01-26 | 144 | 0 |
| K133212 | ZELTIQ COOLSCULPTING SYSTEM | Zeltiq Aesthetics, Inc. | 2014-04-09 | 173 | 0 |
| K120023 | ZELTIQ COOLSCULPTING | Zeltiq Aesthetics, Inc. | 2012-05-02 | 120 | 0 |
| DEN090002 | ZELTIQ AESTHETICS DERMAL COOLING DEVICE | Zeltiq Aesthetics | 2010-08-24 | 315 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda