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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Cryosurgical, Accessories
510(k) Number K253348
Device Name TargetCool-e
Applicant
Recensmedical, Inc.
#507, #908, Sk V1 Center, 830 Dongtansunhwan-Daero
Hwaseong-Si,  KR 18468
Applicant Contact Minju Choi
Correspondent
Recensmedical, Inc.
#507, #908, Sk V1 Center, 830 Dongtansunhwan-Daero
Hwaseong-Si,  KR 18468
Correspondent Contact Minju Choi
Regulation Number878.4350
Classification Product Code
GEH  
Subsequent Product Code
MLY  
Date Received09/30/2025
Decision Date 10/15/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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