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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Phacofragmentation
510(k) Number K122829
Device Name LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS
Applicant
LENSAR, INC.
2800 DISCOVERY DRIVE
SUITE 100
ORLANDO,  FL  32826
Applicant Contact SHIRLEY K MCGARVEY
Correspondent
LENSAR, INC.
2800 DISCOVERY DRIVE
SUITE 100
ORLANDO,  FL  32826
Correspondent Contact SHIRLEY K MCGARVEY
Regulation Number886.4670
Classification Product Code
HQC  
Date Received09/17/2012
Decision Date 12/03/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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