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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 K980685
Device Name MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS
Applicant
LUMENIS, INC.
3270 WEST BAYSHORE RD.
POST OFFICE BOX 10122
PALO ALTO,  CA  94303 -0810
Applicant Contact ANNE WORDEN
Correspondent
LUMENIS, INC.
3270 WEST BAYSHORE RD.
POST OFFICE BOX 10122
PALO ALTO,  CA  94303 -0810
Correspondent Contact ANNE WORDEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/23/1998
Decision Date 05/20/1998
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
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