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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmic Femtosecond Laser
510(k) Number K101626
Device Name LENSX LASER SYSTEM
Applicant
Lensx Lasers, Inc.
733 Bolsana Dr.
Laguna Beach,  CA  92651
Applicant Contact Judy Gordon
Correspondent
Lensx Lasers, Inc.
733 Bolsana Dr.
Laguna Beach,  CA  92651
Correspondent Contact Judy Gordon
Regulation Number886.4390
Classification Product Code
OOE  
Subsequent Product Code
HQC  
Date Received06/09/2010
Decision Date 10/18/2010
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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