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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name stimulator, transcutaneous electrical, aesthetic purposes
510(K) Number K120511
Device Name AGELESS WONDER FACIAL MUSCLE STIMULATION SYSTEM
Applicant
LETO ENTERPRISE LTD.
308 hennessy rd
wanchai, 
Contact sabrina wei
Regulation Number882.5890
Classification Product Code
NFO  
Date Received02/21/2012
Decision Date 07/30/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-