CoolAdhesive Gel Pad (Medium)
CoolAdhesive Gel Pad (Medium) package contains ten pads. Package represents the lowest marketed level.
3manufacturers in China registered for this device type
1catalogue number
13510(k) clearances naming this product code
6recalls on this code
Who Else Makes It
Concentrated in Guangdong (1), Beijing (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Beijing Spiritlaser Science & Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 21 |
| Shandong Moonlight Electronics Tech Co., Ltd. | Weifang | Shandong | Manufacturer | 11 |
Record
| Listed by | Zeltiq Aesthetics Inc., United States |
|---|---|
| FDA product code | OOK |
| Device type | Dermal Cooling Pack/Vacuum/Massager |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4340 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2020-08-31 |
| Record revised | 2024-05-01 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CS-GL-MED-10-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoolSculpting Elite | Zeltiq Aesthetics Inc. | 6 |
| CoolAdvantage Card | Zeltiq Aesthetics Inc. | 6 |
| CoolAdvantage Plus Card | Zeltiq Aesthetics Inc. | 5 |
| CoolCard | Zeltiq Aesthetics Inc. | 5 |
| CoolAdvantage Petite Card | Zeltiq Aesthetics Inc. | 5 |
| CoolCard Max | Zeltiq Aesthetics Inc. | 5 |
| CoolMini Card | Zeltiq Aesthetics Inc. | 5 |
| CoolSmooth Card | Zeltiq Aesthetics Inc. | 5 |
| CoolSmooth PRO Card | Zeltiq Aesthetics Inc. | 5 |
| CoolCurve+ Applicator | Zeltiq Aesthetics Inc. | 2 |
| CoolSmooth Securement System | Zeltiq Aesthetics Inc. | 2 |
| Gel Trap, CoolAdvantage | Zeltiq Aesthetics Inc. | 2 |
Showing 12 of 110. All products under Dermal Cooling Pack/Vacuum/Massager
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212707 | 2021-11-05 |
| K193566 | 2020-01-21 |
| K183514 | 2019-01-14 |
| K181740 | 2018-08-29 |
| K172144 | 2017-11-01 |
| K171069 | 2017-07-07 |
| K162050 | 2016-11-21 |
| K160259 | 2016-03-23 |
| K151179 | 2015-09-22 |
| K142491 | 2015-01-26 |
| K133212 | 2014-04-09 |
| K120023 | 2012-05-02 |
| DEN090002 | 2010-08-24 |
Recalls
6 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-06-09 | Class II | Unknown/Undetermined by firm | 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 timeframe. | 703 units | |
| 2022-06-09 | Class II | Unknown/Undetermined by firm | 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 timeframe. | 2,945 units | |
| 2022-06-09 | Class II | Unknown/Undetermined by firm | 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 timeframe. | 2,686 units | |
| 2022-06-09 | Class II | Unknown/Undetermined by firm | 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 timeframe. | 2,684 units | |
| 2022-06-09 | Class II | Unknown/Undetermined by firm | 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 timeframe. | 3,054 units | |
| 2021-07-05 | Class II | Software design | 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) Not reporting a thermal event or any other error codes causi | 911 systems (update 08/23/2021 = 1105 systems) | 2023-11-09 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.