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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 K052526
Device Name NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES
Applicant
Lumenis, Inc.
2400 Condensa St.
Santa Clara,  CA  95051
Applicant Contact KAREN L BAKER
Correspondent
Lumenis, Inc.
2400 Condensa St.
Santa Clara,  CA  95051
Correspondent Contact KAREN L BAKER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/14/2005
Decision Date 11/15/2005
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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