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 Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
510(k) Number K222012
Device Name FAQ 101
Applicant
Foreo, Inc.
1525 E Pama Ln.
Las Vegas,  NV  89119
Applicant Contact Laura Hoshue
Correspondent
Foreo, Inc.
1525 E Pama Ln.
Las Vegas,  NV  89119
Correspondent Contact Danijela Domlijanovic
Regulation Number878.4420
Classification Product Code
PAY  
Subsequent Product Code
OHS  
Date Received07/08/2022
Decision Date 04/05/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-