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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 K011703
Device Name LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICES
Applicant
LUMENIS
2400 CONDENSA ST.
SANTA CLARA,  CA  95051
Applicant Contact LISA MCGRATH
Correspondent
LUMENIS
2400 CONDENSA ST.
SANTA CLARA,  CA  95051
Correspondent Contact LISA MCGRATH
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/01/2001
Decision Date 08/29/2001
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
Recalls CDRH Recalls
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