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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K051944
Device Name FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES
Applicant
Lumenis, Inc.
2400 Condensa St.
Santa Clara,  CA  95051
Applicant Contact KAREN L BAKER
Correspondent
Lumenis, Inc.
2400 Condensa St.
Santa Clara,  CA  95051
Correspondent Contact KAREN L BAKER
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Code
GEX  
Date Received07/18/2005
Decision Date 09/30/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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