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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 K974789
Device Name COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L
Applicant
Lumenis, Inc.
3270 W. Bayshore Rd.
Post Office Box 10122
Palo Alto,  CA  94303 -0810
Applicant Contact MICHELE DEETON
Correspondent
Lumenis, Inc.
3270 W. Bayshore Rd.
Post Office Box 10122
Palo Alto,  CA  94303 -0810
Correspondent Contact MICHELE DEETON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received12/22/1997
Decision Date 03/09/1998
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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