Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Dermal Cooling Pack/Vacuum/Massager
510(k) Number K233732
Device Name CoolSculpting Elite System
Applicant
Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics
And Now, An Abbvie, Inc. Company)
4410 Rosewood Dr.
Pleasanton,  CA  94588
Applicant Contact Victoria Montemayor
Correspondent
Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics
And Now, An Abbvie, Inc. Company)
4410 Rosewood Dr.
Pleasanton,  CA  94588
Correspondent Contact Victoria Montemayor
Regulation Number878.4340
Classification Product Code
OOK  
Date Received11/21/2023
Decision Date 09/12/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-