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 Powered Surgical Instrument For Improvement In The Appearance Of Cellulite
510(k) Number K134010
Device Name CABOCHON SYSTEM
Applicant
Cabochon Aesthetics, Inc.
127 Independence Dr.
Menlo Park,  CA  94025
Applicant Contact BEN F BRIAN, PH.D.
Correspondent
Cabochon Aesthetics, Inc.
127 Independence Dr.
Menlo Park,  CA  94025
Correspondent Contact BEN F BRIAN, PH.D.
Regulation Number878.4790
Classification Product Code
OUP  
Date Received12/30/2013
Decision Date 04/14/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT01671839
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-