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FDA 510(k), K151179, ZELTIQ CoolSculpting System
FDA 510(k), K151179, ZELTIQ CoolSculpting System
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510(K) Number: K151179
Device Name: ZELTIQ CoolSculpting System
Manufacturer: SHRUTI JAYAKUMAR
Device Classification Name: Dermal Cooling Pack/Vacuum/Massager
Regulation Number: OOK
Classification Product Code: KXA
Date Received: 05/04/2015
Decision Date: 09/22/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
Device Name: ZELTIQ CoolSculpting System
Manufacturer: SHRUTI JAYAKUMAR
Device Classification Name: Dermal Cooling Pack/Vacuum/Massager
Regulation Number: OOK
Classification Product Code: KXA
Date Received: 05/04/2015
Decision Date: 09/22/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: General & Plastic Surgery
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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