FDA 510(k) Application Details - DEN090002

Device Classification Name

  More FDA Info for this Device
510(K) Number DEN090002
Device Name ZELTIQ AESTHETICS DERMAL COOLING DEVICE
Applicant ZELTIQ AESTHETICS
4698 WILLOW ROAD
PLEASANTON, CA 94588 US
Other 510(k) Applications for this Company
Contact LOUIS-PIERRE MARCOUX
Other 510(k) Applications for this Contact
Regulation Number

  More FDA Info for this Regulation Number
Classification Product Code OOK
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 10/13/2009
Decision Date 08/24/2010
Decision DENG -
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type Post-NSE
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact