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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 K233962
Device Name ReBorn (1050nm)
Applicant
Lightfective , Ltd.
2 Hatochen St.
Caesarea,  IL 3079533
Applicant Contact Tsvi Bahat
Correspondent
A. Stein - Regulatory Affairs Consulting , Ltd.
18 Hata'As St.
Kfar Saba,  IL 4442518
Correspondent Contact Ahava Stein
Regulation Number878.5400
Classification Product Code
PKT  
Date Received12/15/2023
Decision Date 04/16/2024
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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