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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 K895143
Device Name COHERENT XA-50, X30/CW, XA30/SP SURGICAL LASERS
Applicant
LUMENIS, INC.
3270 WEST BAYSHORE RD.
POST OFFICE BOX 10122
PALO ALTO,  CA  94303 -0810
Applicant Contact VIRGINIA SINGER
Correspondent
LUMENIS, INC.
3270 WEST BAYSHORE RD.
POST OFFICE BOX 10122
PALO ALTO,  CA  94303 -0810
Correspondent Contact VIRGINIA SINGER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/18/1989
Decision Date 09/25/1989
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
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