Home › Device types › OOK
Dermal Cooling Pack/Vacuum/Massager
FDA product code OOK · Class 2 · General, Plastic Surgery
150
Registered devices
11,387
Adverse events
6
Recalls
14
510(k) clearances
Devices with this code
CoolSmooth Foam Borders — Zeltiq Aesthetics, Inc.CoolCard Max — Zeltiq Aesthetics, Inc.CoolAdhesive Gel Pad (Large) — Zeltiq Aesthetics, Inc.CoolMini Card — Zeltiq Aesthetics, Inc.CoolAdvantage Gasket — Zeltiq Aesthetics, Inc.Contour, CoolCurve+ CoolAdvantage — Zeltiq Aesthetics, Inc.CoolSmooth Liner — Zeltiq Aesthetics, Inc.CoolMini Card — Zeltiq Aesthetics, Inc.CoolSculpting Elite Card, Direct, US/CA, Solo,50Tx — Zeltiq Aesthetics, Inc.CoolCurve+ Applicator — Zeltiq Aesthetics, Inc.CoolSmooth PRO Card — Zeltiq Aesthetics, Inc.CoolSculpting System Applicator Flat 125 (F125) — Zeltiq Aesthetics, Inc.CoolAdvantage Petite — Zeltiq Aesthetics, Inc.CoolAdvantage Petite Card — Zeltiq Aesthetics, Inc.CoolSmooth PRO Card — Zeltiq Aesthetics, Inc.CoolSculpting System Applicators Curve 80 (C80) — Zeltiq Aesthetics, Inc.CoolCurve Applicator — Zeltiq Aesthetics, Inc.CoolSculpting Umbilical Cable Assembly 2.6m — Zeltiq Aesthetics, Inc.CoolAdvantage Plus Card — Zeltiq Aesthetics, Inc.CoolAdhesive Petite Pad — Zeltiq Aesthetics, Inc.CoolSculpting Quad Comfort Strap — Zeltiq Aesthetics, Inc.CoolAdvantage Card — Zeltiq Aesthetics, Inc.CoolAdhesive Gel Pad (Small) — Zeltiq Aesthetics, Inc.CoolSculpting System Applicator Flat 165 (F165) — Zeltiq Aesthetics, Inc.
Recent 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| 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 |
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