Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Zeltiq Aesthetics · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K172144 | CoolSculpting System | Zeltiq Aesthetics | 2017-11-01 | 107 | 0 |
| DEN090002 | ZELTIQ AESTHETICS DERMAL COOLING DEVICE | Zeltiq Aesthetics | 2010-08-24 | 315 | 0 |
| K090094 | ZELTIQ SYSTEM | Zeltiq Aesthetics | 2009-05-20 | 126 | 0 |
| K080118 | ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE | Zeltiq Aesthetics | 2008-05-02 | 106 | 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