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FDA 510(k), K142491, ZEL TIQ CoolSculpting System
FDA 510(k), K142491, ZEL TIQ CoolSculpting System
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510(K) Number: K142491
Device Name: ZEL TIQ CoolSculpting System
Manufacturer: SHRUTI JAYAKUMAR
Device Classification Name: Dermal Cooling Pack/Vacuum/Massager
Regulation Number: OOK
Classification Product Code: 09/04/2014
Date Received: 01/26/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: ZEL TIQ CoolSculpting System
Manufacturer: SHRUTI JAYAKUMAR
Device Classification Name: Dermal Cooling Pack/Vacuum/Massager
Regulation Number: OOK
Classification Product Code: 09/04/2014
Date Received: 01/26/2015
Decision Date: Substantially Equivalent (SESE)
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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