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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser For Disruption Of Adipocyte Cells For Aesthetic Use
510(k) Number K240658
Device Name 1060nm laser body slimming machine
Applicant
Hebei JT Medical Co., Ltd.
C12 Hegu Industrial Park, Chaoyang Rd.,
Development Zone Zhuozhou City
Hebei,  CN
Applicant Contact Karen Liu
Correspondent
Beijing Styh Medical Technology Service Co. , Ltd.
#18, Jianshe Rd., Kaixuan St., Liangxiang Town,
Fangshan District
Beijing,  CN 102488
Correspondent Contact Gina Lian
Regulation Number878.5400
Classification Product Code
PKT  
Date Received03/08/2024
Decision Date 05/13/2024
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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