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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 K060338
Device Name FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO
Applicant
Lumenis, Inc.
2400 Condensa St.
Santa Clara,  CA  95051
Applicant Contact Connie Hoy
Correspondent
Lumenis, Inc.
2400 Condensa St.
Santa Clara,  CA  95051
Correspondent Contact Connie Hoy
Regulation Number878.4810
Classification Product Code
GEX  
Date Received02/10/2006
Decision Date 03/09/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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