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CDRH Petitions
… LLP Requesting FDA issue an order declaring Zeltiq CoolSculpting System to be NSE 05/29/2015 10/08/2015 …
November 2021 510(K) Clearances
… CN 518116 510(k) SUMMARY AVAILABLE FROM FDA DEVICE: CoolSculpting Elite System Zeltiq Aesthetics, Inc. 510(k) NO: …
FDA FOIA Closed Log - June 2019
… Closed 06/27/2019 2018-9111 COLSON HICKS EIDSON LAW FIRM COOLSCULPTING ADVERSE EVENTS Closed 06/26/2019 2018-9127 Dr. …
Closed FOIA Log - January 2021
… Closed 2018-2204 Brodhead Law, LLC ZELTIQ AESTHETICS INC - COOLSCULPTING K133212 APRVL RECS Withdrawn Closed w/o Charges …
FDA FOIA Closed Log - July 2022
… K173619 Closed 2019-2242 COVAL-GOLDSMITH, SHERRIE ZELTIQ COOLSCULPTING SYS K142491 Closed 2019-2818 ASSOCIATED PRESS …
Closed FOIA Log - September 2020
… Brodhead Law, LLC 04/13/2018 ZELTIQ AESTHERICS INC - COOLSCULPTING K160259 APRVL RECS Withdrawn Closed w/o Charges …
FDA FOIA Log November 2018
… RECS 2018-9111 11/08/2018 COLSON HICKS EIDSON LAW FIRM COOLSCULPTING ADVERSE EVENTS 2018-9112 11/08/2018 KIRKLAND & …
FDA FOIA Closed Log - June 2019
… (FCN) program 2018-9111 COLSON HICKS EIDSON LAW FIRM COOLSCULPTING ADVERSE EVENTS 2018-9127 Dr. Michael Zhadkevich …
Closed FOIA Log - May 2020
… w/o Charge 2019-2241 COVAL-GOLDSMITH, SHERRIE ZELTIQ COOLSCULPTING SYS K133212 Withdrawn Closed w/o Charge …