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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 K152722
Device Name neoV980 & neoV1470 Diode Lasers
Applicant
G.N.S Neolaser , Ltd.
7 Ha'Eshel St.
Caesarea,  IL 38900
Applicant Contact GIL SHAPIRA
Correspondent
G.N.S Neolaser , Ltd.
7 Ha'Eshel St.
Caesarea,  IL 38900
Correspondent Contact GIL SHAPIRA
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/22/2015
Decision Date 12/08/2015
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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