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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 K100384
FOIA Releasable 510(k) K100384
Device Name FIBERLASE C02 LASER WAVEGUIDE
Applicant
Lumenis, Ltd.
20 Hataas St. (Pob 124)
Kfar Saba,  IL 44425
Applicant Contact AHAVA STEIN
Correspondent
Lumenis, Ltd.
20 Hataas St. (Pob 124)
Kfar Saba,  IL 44425
Correspondent Contact AHAVA STEIN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/16/2010
Decision Date 04/12/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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