FDA product code OOK: Dermal Cooling Pack/Vacuum/Massager
OOK is the FDA product code for dermal cooling pack/vacuum/massager. It is a Class II device, regulated under 21 CFR 878.4340 and reviewed by the General and Plastic Surgery panel. FDA has cleared 13 510(k) submissions under OOK, 1 in the last five years, from 3 different applicants. The average 510(k) review took 110 days (median 107); 296 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 6 recalls for OOK devices, 5 initiated in the last five years.
Definition
The device is a combination of a cooling pad associated with a vacuum or mechanical massager intended for the disruption or induction of adipocyte cells indicated for body contouring or reduction in circumference of body areas.
Classification
| Field | Value |
|---|---|
| Device name | Dermal Cooling Pack/Vacuum/Massager |
| Device class | Class II |
| Regulation | 21 CFR 878.4340 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for OOK
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 98 |
| 2018 | 1 | 58 |
| 2019 | 1 | 27 |
| 2020 | 1 | 29 |
| 2021 | 1 | 71 |
| 2024 | 1 | 296 |
Compare with all 510(k) review times · Search every OOK clearance
Top OOK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Zeltiq Aesthetics, Inc. | 11 | 2021-11-05 |
| Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics | 1 | 2024-09-12 |
| Zeltiq Aesthetics | 1 | 2017-11-01 |
Most recent OOK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K233732 | Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics | CoolSculpting Elite System | 2024-09-12 | 296 |
| K212707 | Zeltiq Aesthetics, Inc. | CoolSculpting Elite System | 2021-11-05 | 71 |
| K193566 | Zeltiq Aesthetics, Inc. | ZELTIQ CoolSculpting System | 2020-01-21 | 29 |
| K183514 | Zeltiq Aesthetics, Inc. | ZELTIQ CoolSculpting System | 2019-01-14 | 27 |
| K181740 | Zeltiq Aesthetics, Inc. | ZELTIQ CoolSculpting System | 2018-08-29 | 58 |
Recalls for OOK devices
6 product recalls in 2 recall events; 5 initiated in the last five years and 5 still open. Most recent: 2022-06-09.
| Year | Recalls |
|---|---|
| 2021 | 1 |
| 2022 | 5 |
Frequently asked questions
What is FDA product code OOK?
OOK is the FDA product code for dermal cooling pack/vacuum/massager. It is a Class II device, regulated under 21 CFR 878.4340 and reviewed by the General and Plastic Surgery panel.
What device class is OOK?
Class II, regulation 21 CFR 878.4340. Typical premarket route: 510(k).
How long does a 510(k) take for product code OOK?
Across 13 cleared submissions the average was 110 days from receipt to decision (median 107).
Which companies have the most OOK clearances?
Zeltiq Aesthetics, Inc. (11); Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics (1); Zeltiq Aesthetics (1).
Have OOK devices been recalled?
Yes: 6 product recalls across 2 recall events; the most recent began 2022-06-09.
Next steps
- Run an FDA pathway report with predicate devices for product code OOK
- Run a recall and safety report across every OOK manufacturer
- Watch product code OOK for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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