510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OOKClass II

Dermal Cooling Pack/Vacuum/Massager

21 CFR 878.4340 / General, Plastic Surgery
FDA source (opens on fda.gov)

OOK is the FDA product code for Dermal Cooling Pack/Vacuum/Massager, a class II device type, regulated under 21 CFR 878.4340. FDA's definition for this code reads: "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". As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
OOK
Device name
Dermal Cooling Pack/Vacuum/Massager
FDA 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.
Regulation
21 CFR 878.4340
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
14
Ingested recalls
6

Clearances, product code OOK

By decision year
14 clearances under product code OOK with a decision year between 2010 and 2024, 2015 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OOK by decision year
YearClearances
20101
20121
20141
20152
20162
20172
20181
20191
20201
20211
20241

Applicants with the most clearances

Product code OOK
Applicants holding the most 510(k) clearances under product code OOK
ApplicantClearances
Zeltiq Aesthetics Inc13
Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order