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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 K133319
Device Name ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060
Applicant
Lumenis, Ltd.
6 Hakidma St., Yokneam Industrial Park
P.O. Box 240
Yokneam,  IL 2069204
Applicant Contact IMAN KHORSHID
Correspondent
Boston Scientific
100 Boston Scientific Way
Marlboro,  MA  01752
Correspondent Contact Donn M Gardner
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/28/2013
Decision Date 03/20/2014
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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