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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 K895518
Device Name COHERENT HOLMIUM:YAG SURGICAL LASER
Applicant
Lumenis, Inc.
3270 W. Bayshore Rd.
Post Office Box 10122
Palo Alto,  CA  94303
Applicant Contact VIRGINIA SINGER
Correspondent
Lumenis, Inc.
3270 W. Bayshore Rd.
Post Office Box 10122
Palo Alto,  CA  94303
Correspondent Contact VIRGINIA SINGER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/12/1989
Decision Date 11/30/1989
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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