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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
Applicant Contact KAREN BAKER
Correspondent
Lumenis, Inc.
2400 Condensa St.
Santa Clara,  CA  95051
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
Predetermined Change
Control Plan Authorized		 No
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