Medical Device Manufacturer · US , Winter Park , FL

Lensar, Inc. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2010

Recent clearances: ALLY Adaptive Cataract Treatment System, LENSAR Laser System - fs 3D (LLS-fs 3D), LENSAR Laser System - fs 3D (LLS-fs 3D)

14
Total
14
Cleared
0
Denied

FDA 510(k) Regulatory Record - Lensar, Inc. Ophthalmic ✕

14 devices
1-14 of 14
Cleared Jun 09, 2022
ALLY Adaptive Cataract Treatment System
K220259 · OOE
Ophthalmic · 129d
Cleared Dec 21, 2018
LENSAR Laser System - fs 3D (LLS-fs 3D)
K182795 · OOE
Ophthalmic · 81d
Cleared Aug 09, 2018
LENSAR Laser System - fs 3D (LLS-fs 3D)
K181430 · OOE
Ophthalmic · 69d
Cleared Mar 02, 2018
LENSAR Laser System - fs 3D (LLS-fs 3D)
K173346 · OOE
Ophthalmic · 128d
Cleared Aug 10, 2017
LENSAR Laser System – fs 3D (LLS-fs 3D)
K171337 · OOE
Ophthalmic · 94d
Cleared May 05, 2017
LENSAR Laser System - fs 3D (LLS-fs 3D)
K170576 · OOE
Ophthalmic · 67d
Cleared Oct 15, 2015
LENSAR Laser System - fs 3D (LLS-fs 3D)
K152453 · OOE
Ophthalmic · 48d
Cleared Mar 20, 2015
LENSAR Laser System - fs 3D
K143010 · OOE
Ophthalmic · 151d
Cleared Mar 27, 2013
TBD
K123859 · OOE
Ophthalmic · 103d
Cleared Dec 03, 2012
LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS
K122829 · HQC
Ophthalmic · 77d
Cleared Jun 08, 2012
TBD
K120214 · OOE
Ophthalmic · 136d
Cleared Oct 19, 2011
TBD
K112098 · OOE
Ophthalmic · 89d
Cleared Mar 16, 2011
LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY
K102727 · OOE
Ophthalmic · 175d
Cleared May 13, 2010
LENSAR LASER SYSTEM
K090633 · OOE
Ophthalmic · 430d
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