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 K232153
Device Name Avéli
Applicant
Revelle Aesthetics, Inc.
2570 W. El Camino Real, Suite 310
Mountain View,  CA  94040
Applicant Contact Melissa Viotti
Correspondent
Revelle Aesthetics, Inc.
2570 W. El Camino Real, Suite 310
Mountain View,  CA  94040
Correspondent Contact Melissa Viotti
Regulation Number878.4790
Classification Product Code
OUP  
Subsequent Product Codes
FTD   GDI  
Date Received07/19/2023
Decision Date 08/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-