Medical Device Manufacturer · US , Winter Park , FL

Lensar, Inc.

14 submissions · 14 cleared · Since 2010
14
Total
14
Cleared
0
Denied

Lensar, Inc. — FDA 510(k) Submissions

Lensar, Inc. has submitted 14 FDA 510(k) premarket notifications since 2010, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Ophthalmic Femtosecond Laser, Unit, Phacofragmentation . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
ALLY Adaptive Cataract Treatment System
K220259 · OOE Ophthalmic Femtosecond Laser · Ophthalmic
Jun 2022 129d
LENSAR Laser System - fs 3D (LLS-fs 3D)
K182795 · OOE Ophthalmic Femtosecond Laser · Ophthalmic
Dec 2018 81d
LENSAR Laser System - fs 3D (LLS-fs 3D)
K181430 · OOE Ophthalmic Femtosecond Laser · Ophthalmic
Aug 2018 69d
LENSAR Laser System - fs 3D (LLS-fs 3D)
K173346 · OOE Ophthalmic Femtosecond Laser · Ophthalmic
Mar 2018 128d
LENSAR Laser System ? fs 3D (LLS-fs 3D)
K171337 · OOE Ophthalmic Femtosecond Laser · Ophthalmic
Aug 2017 94d
LENSAR Laser System - fs 3D (LLS-fs 3D)
K170576 · OOE Ophthalmic Femtosecond Laser · Ophthalmic
May 2017 67d
LENSAR Laser System - fs 3D (LLS-fs 3D)
K152453 · OOE Ophthalmic Femtosecond Laser · Ophthalmic
Oct 2015 48d
LENSAR Laser System - fs 3D
K143010 · OOE Ophthalmic Femtosecond Laser · Ophthalmic
Mar 2015 151d
TBD
K123859 · OOE Ophthalmic Femtosecond Laser · Ophthalmic
Mar 2013 103d
LENSAR LASER SYSTEM - FS 3D FOR CORNEAL INCISIONS
K122829 · HQC Unit, Phacofragmentation · Ophthalmic
Dec 2012 77d
TBD
K120214 · OOE Ophthalmic Femtosecond Laser · Ophthalmic
Jun 2012 136d
TBD
K112098 · OOE Ophthalmic Femtosecond Laser · Ophthalmic
Oct 2011 89d
LENSAR LASER SYSTEM FOR ANTERIOR CAPSULOTOMY
K102727 · OOE Ophthalmic Femtosecond Laser · Ophthalmic
Mar 2011 175d
LENSAR LASER SYSTEM
K090633 · OOE Ophthalmic Femtosecond Laser · Ophthalmic
May 2010 430d
Filters
All14 Ophthalmic 14