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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 K951812
Device Name MODIFIED COHERENT ULTRAPULSE CO2 SURGICAL LASERS
Applicant
Lumenis, Inc.
3270 W. Bayshore Rd.
Post Office Box 10122
Palo Alto,  CA  94303
Applicant Contact ANNE WORDEN
Correspondent
Lumenis, Inc.
3270 W. Bayshore Rd.
Post Office Box 10122
Palo Alto,  CA  94303
Correspondent Contact ANNE WORDEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/19/1995
Decision Date 07/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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