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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Comb, Hair
510(k) Number K222790
Device Name F65 Laser System
Applicant
Lumenis Be, Ltd.
6 Hakidma St. P.O. Box 240
Yokneam,  IL 2069204
Applicant Contact Shlomit Segman
Correspondent
Lumenis Be, Ltd.
6 Hakidma St. P.O. Box 240
Yokneam,  IL 2069204
Correspondent Contact Shlomit Segman
Regulation Number890.5500
Classification Product Code
OAP  
Date Received09/15/2022
Decision Date 06/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
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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