FDA Product Code OOK: Dermal Cooling Pack/vacuum/massager
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.
Leading manufacturers include Zeltiq Aesthetics, Inc. and Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics.
FDA 510(k) Cleared Dermal Cooling Pack/vacuum/massager Devices (Product Code OOK)
About Product Code OOK - Regulatory Context
510(k) Submission Activity
14 total 510(k) submissions under product code OOK since 2010, with 13 receiving FDA clearance (average review time: 124 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under OOK have taken an average of 296 days to reach a decision - up from 111 days historically. Manufacturers should account for longer review timelines in current project planning.
OOK devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →