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 K242227
Device Name GENEO X ELITE
Applicant
Pollogen, Ltd.
6 Kaufman St.
Pob 50320
Tel Aviv,  IL 6801298
Applicant Contact Karen Smith
Correspondent
The RC Insight Group, LLC
82 County Rd.
#84
Mattapoisett,  MA  02739
Correspondent Contact Lori Marzilli-Kahler
Regulation Number878.4420
Classification Product Code
PAY  
Subsequent Product Code
ISA  
Date Received07/30/2024
Decision Date 10/12/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-