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 stimulator, transcutaneous electrical, aesthetic purposes
510(k) Number K191672
Device Name NuFACE Mini Device
Applicant
Carol Cole Company dba NuFACE
1325 Sycamore Avenue, Suite A
Vista,  CA  92081
Applicant Contact Nadia Vazirzadeh Miller
Correspondent
Carol Cole Company dba NuFACE
1325 Sycamore Avenue, Suite A
Vista,  CA  92081
Correspondent Contact Nadia Vazirzadeh Miller
Regulation Number882.5890
Classification Product Code
NFO  
Date Received06/24/2019
Decision Date 10/15/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-