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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K253803
Device Name MILAN System
Applicant
Lumenis Be, Ltd.
Hakidma St. 9, P.O.B 426
Yokneam Ilit,  IL 2069236
Applicant Contact Shlomit Segman
Correspondent
Lumenis Be, Ltd.
Hakidma St. 9, P.O.B 426
Yokneam Ilit,  IL 2069236
Correspondent Contact Shlomit Segman
Regulation Number878.4400
Classification Product Code
GEI  
Date Received11/28/2025
Decision Date 06/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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