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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 K151331
Device Name The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch
Applicant
Lumenis, Ltd.
6 Hakidma St. P.O. Box 240
Yokneam,  IL 2069204
Applicant Contact ELISSA BURG
Correspondent
Lumenis, Ltd.
6 Hakidma St. P.O. Box 240
Yokneam,  IL 2069204
Correspondent Contact ELISSA BURG
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/19/2015
Decision Date 06/30/2015
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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