Home › Device types › OOK
Dermal Cooling Pack/Vacuum/Massager
FDA product code OOK · Class 2 · General, Plastic Surgery
155
Registered devices
11,526
Adverse events
6
Recalls
14
510(k) clearances
Devices with this code
CoolAdvantage Petite Card — Zeltiq Aesthetics, Inc.CoolGel Mini — Zeltiq Aesthetics, Inc.CoolMini Card — Zeltiq Aesthetics, Inc.CoolSculpting Elite — Zeltiq Aesthetics, Inc.CoolSculpting Solo — Zeltiq Aesthetics, Inc.CoolMini Securement Straps — Zeltiq Aesthetics, Inc.CoolSmooth PRO Card — Zeltiq Aesthetics, Inc.CoolSmooth — Zeltiq Aesthetics, Inc.Contour, CoolCurve+ CoolAdvantage — Zeltiq Aesthetics, Inc.CoolMini Support Arm System — Zeltiq Aesthetics, Inc.CoolCard — Zeltiq Aesthetics, Inc.CoolAdvantage Plus Card — Zeltiq Aesthetics, Inc.CoolAdvantage Petite Card — Zeltiq Aesthetics, Inc.CoolSculpting System Applicator Flat 125 (F125) — Zeltiq Aesthetics, Inc.CoolSmooth Card — Zeltiq Aesthetics, Inc.CoolSculpting System Applicator Curve 150 (C150) — Zeltiq Aesthetics, Inc.CoolMax Applicator — Zeltiq Aesthetics, Inc.CoolAdvantage Core — Zeltiq Aesthetics, Inc.CoolAdvantage Plus, Gasket — Zeltiq Aesthetics, Inc.CoolAdvantage Plus Card — Zeltiq Aesthetics, Inc.CoolAdhesive Gel Pad (Small) — Zeltiq Aesthetics, Inc.CoolAdhesive Gel Pad (Large) — Zeltiq Aesthetics, Inc.CoolGel — Zeltiq Aesthetics, Inc.CoolSculpting Elite Quick-Check Card, 99 cycle — 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 |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.