510(k) K212707
- Device
- CoolSculpting Elite System
- Applicant
- Zeltiq Aesthetics, Inc.
- 510(k) number
- K212707
- Product code
- OOK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-11-05
- Date received
- 2021-08-26
- Regulation
- 878.4340
- Classification name
- Dermal Cooling Pack/vacuum/massager
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Vicky Chai
- Address
- 4410 Rosewood Dr. Pleasanton CA US 94588 94588
FDA Registration Numbers#
- 3027605507
- 9681572
- 3011837770
- 3014214244
- 2011068
- 3012441529
- 3028011
- 3023281311
- 3009736547
- 3002807401
- 3007215625
- 3001415205
- 3017132875
- 3003890514
- 9617229
- 3008959444
- 3020978007
- 1000150986
- 3009974688
Source Documents#
Other 510(k) Records For Product Code OOK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233732 | CoolSculpting Elite System | Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics | 2024-09-12 |
| K193566 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2020-01-21 |
| K183514 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2019-01-14 |
| K181740 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2018-08-29 |
| K172144 | CoolSculpting System | Zeltiq Aesthetics | 2017-11-01 |
| K171069 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2017-07-07 |
| K162050 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2016-11-21 |
| K160259 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2016-03-23 |
| K151179 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2015-09-22 |
| K142491 | ZEL TIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2015-01-26 |
| K133212 | ZELTIQ COOLSCULPTING SYSTEM | Zeltiq Aesthetics, Inc. | 2014-04-09 |
| K120023 | ZELTIQ COOLSCULPTING | Zeltiq Aesthetics, Inc. | 2012-05-02 |
| DEN090002 | ZELTIQ AESTHETICS DERMAL COOLING DEVICE | Zeltiq Aesthetics | 2010-08-24 |
Legacy Summary#
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FDA Review#
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