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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 K004006
Device Name SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER
Applicant
LUMENIS, INC.
2400 CONDENSA ST.
SANTA CLARA,  CA  95051 -0901
Applicant Contact KAREN BAKER
Correspondent
LUMENIS, INC.
2400 CONDENSA ST.
SANTA CLARA,  CA  95051 -0901
Correspondent Contact KAREN BAKER
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Code
HQF  
Date Received12/26/2000
Decision Date 03/26/2001
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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