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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 K233301
Device Name ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories
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  
Date Received09/29/2023
Decision Date 12/01/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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