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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K241973
Device Name SmartIPL_NI 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 Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
ONF   QIU  
Date Received07/05/2024
Decision Date 09/19/2026
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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