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FDA 510(k), K162050, ZELTIQ CoolSculpting System
FDA 510(k), K162050, ZELTIQ CoolSculpting System
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510(K) Number: K162050
Device Name: ZELTIQ CoolSculpting System
Manufacturer: ZELTIQ Aesthetics, Inc
Device Classification Name: dermal cooling pack/vacuum/massager
Regulation Number: 878.4340
Classification Product Code: OOK
Date Received: 07/25/2016
Decision Date: 11/21/2016
Regulation Medical Specialty: General & Plastic Surgery
Device Name: ZELTIQ CoolSculpting System
Manufacturer: ZELTIQ Aesthetics, Inc
Device Classification Name: dermal cooling pack/vacuum/massager
Regulation Number: 878.4340
Classification Product Code: OOK
Date Received: 07/25/2016
Decision Date: 11/21/2016
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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