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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
510(k) Number K231628
Device Name BeShape One™ Device
Applicant
Beshape Technologies , Ltd.
23 Hatas St.
Kfar-Saba,  IL 4442525
Applicant Contact Amit Goren
Correspondent
A. Stein – Regulatory Affairs Consulting , Ltd.
18 Hata’As St. , Suite 21
Kfar Saba,  IL 4442518
Correspondent Contact Amit Goren
Regulation Number878.4590
Classification Product Code
OHV  
Date Received06/05/2023
Decision Date 09/29/2023
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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