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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 K182795
Device Name LENSAR Laser System - fs 3D (LLS-fs 3D)
Applicant
Lensar, Inc.
2800 Discovery Dr., Suite 100
Orlando,  FL  32826
Applicant Contact Keith Peck
Correspondent
Lensar, Inc.
2800 Discovery Dr., Suite 100
Orlando,  FL  32826
Correspondent Contact Keith Peck
Regulation Number886.4390
Classification Product Code
OOE  
Date Received10/01/2018
Decision Date 12/21/2018
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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