ZELTIQ AESTHETICS DERMAL COOLING DEVICE
FDA 510(k) clearance DEN090002 · decided 2010-08-24
Clearance details
- K-number
- DEN090002
- Device name
- ZELTIQ AESTHETICS DERMAL COOLING DEVICE
- Applicant
- Zeltiq Aesthetics
- Decision
- Unknown
- Date received
- 2009-10-13
- Decision date
- 2010-08-24
- Days to decision
- 315 days
- Clearance type
- Post-NSE
- Product code
- OOK
- Device class
- 2
- Regulation number
- 878.4340
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Pleasanton, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CoolSculpting Elite System (K233732) | Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics | 2024-09-12 |
| CoolSculpting Elite System (K212707) | Zeltiq Aesthetics, Inc. | 2021-11-05 |
| ZELTIQ CoolSculpting System (K193566) | Zeltiq Aesthetics, Inc. | 2020-01-21 |
| ZELTIQ CoolSculpting System (K183514) | Zeltiq Aesthetics, Inc. | 2019-01-14 |
| ZELTIQ CoolSculpting System (K181740) | Zeltiq Aesthetics, Inc. | 2018-08-29 |
| CoolSculpting System (K172144) | Zeltiq Aesthetics | 2017-11-01 |
| ZELTIQ CoolSculpting System (K171069) | Zeltiq Aesthetics, Inc. | 2017-07-07 |
| ZELTIQ CoolSculpting System (K162050) | Zeltiq Aesthetics, Inc. | 2016-11-21 |
| ZELTIQ CoolSculpting System (K160259) | Zeltiq Aesthetics, Inc. | 2016-03-23 |
| ZELTIQ CoolSculpting System (K151179) | Zeltiq Aesthetics, Inc. | 2015-09-22 |
| ZEL TIQ CoolSculpting System (K142491) | Zeltiq Aesthetics, Inc. | 2015-01-26 |
| ZELTIQ COOLSCULPTING SYSTEM (K133212) | Zeltiq Aesthetics, Inc. | 2014-04-09 |
Recalls involving this device
No recalls on record reference this clearance.