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CoolAdvantage Petite Core
Zeltiq Aesthetics, Inc. · Model CS-A3-CPC-XX · UDI-DI 00816417021237
OOK
Prescription
10
510(k) clearances
11,387
Adverse events (2 deaths)
6
Recalls
19
Facilities
Description
CoolAdvantage Petite Core Applicator
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-06-09 | Zeltiq Aesthetics, Inc | Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to |
| 2022-06-09 | Zeltiq Aesthetics, Inc | Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to |
| 2022-06-09 | Zeltiq Aesthetics, Inc | Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to |
| 2022-06-09 | Zeltiq Aesthetics, Inc | Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to |
| 2022-06-09 | Zeltiq Aesthetics, Inc | Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to |
| 2021-07-05 | Zeltiq Aesthetics, Inc | An incorrect error messaging system that could potentially lead to: 1) Reporting a thermal event error causing a user to re-treating the affected anatomic area within 24 hours, 2) |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.