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 Unit, Cryosurgical, Accessories
510(k) Number K253114
Device Name TargetCool™ (RM-DT02W)
Applicant
Recensmedical, Inc.
#507, #908, Sk V1 Center, 830 Dongtansunhwan-Daero
Hwaseong-Si,  KR 18468
Applicant Contact Yeonui Lee
Correspondent
Recensmedical, Inc.
#507, #908, Sk V1 Center, 830 Dongtansunhwan-Daero
Hwaseong-Si,  KR 18468
Correspondent Contact Yeonui Lee
Regulation Number878.4350
Classification Product Code
GEH  
Subsequent Product Code
MLY  
Date Received09/24/2025
Decision Date 10/16/2025
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
-
-