OOE · Class II · 21 CFR 886.4390

FDA Product Code OOE: Ophthalmic Femtosecond Laser

Precise Cutting Or Ablation Of Ocular Tissue, Indicated For The Anterior Capsulotomy During Cataract Surgery.

Leading manufacturers include Lensar, Inc., Technolas Perfect Vision GmbH and Alcon Laboratories, Inc..

47
Total
47
Cleared
133d
Avg days
2009
Since
47 devices
25–47 of 47
Cleared Oct 15, 2015
LENSAR Laser System - fs 3D (LLS-fs 3D)
K152453
Lensar, Inc.
Ophthalmic · 48d
Cleared Jun 24, 2015
VICTUS Femtosecond Laser Platform
K151161
Technolas Perfect Vision GmbH
Ophthalmic · 54d
Cleared Mar 20, 2015
LENSAR Laser System - fs 3D
K143010
Lensar, Inc.
Ophthalmic · 151d
Cleared Jan 16, 2015
VICTUS FEMTOSECOND LASER PLATFORM
K141379
Technolas Perfect Vision GmbH
Ophthalmic · 234d
Cleared Sep 30, 2014
WAVELIGHT FS200 LASER SYSTEM
K141476
Alcon Research, Ltd. Dba Alcon Laboratories, Inc.
Ophthalmic · 118d
Cleared Sep 11, 2014
OPTIMEDICA CATALYS PRECISION LASER SYSTEM
K141079
Optimedica Corporation
Ophthalmic · 139d
Cleared Jul 15, 2014
VICTUS FEMTOSECOND LASER PLATFORM
K140615
Technolas Perfect Vision GmbH
Ophthalmic · 127d
Cleared Feb 14, 2014
VICTUS FEMTOSECOND LASER PLATFORM
K132534
Technolas Perfect Vision GmbH
Ophthalmic · 185d
Cleared Mar 27, 2013
TBD
K123859
Lensar, Inc.
Ophthalmic · 103d
Cleared Feb 08, 2013
VICTUS FEMTOSECOND LASER PLATFORM
K122386
Technolas Perfect Vision GmbH
Ophthalmic · 186d
Cleared Dec 12, 2012
LENSX LASER SYSTEM
K123120
Alcon Lensx, Inc.
Ophthalmic · 70d
Cleared Aug 28, 2012
CATALYS PRECISION LASER SYSTEM
K121091
Optimedica Corporation
Ophthalmic · 140d
Cleared Jul 31, 2012
VICTUS LASER PLATFORM
K120426
Technolas Perfect Vision GmbH
Ophthalmic · 169d
Cleared Jun 08, 2012
TBD
K120214
Lensar, Inc.
Ophthalmic · 136d
Cleared Dec 21, 2011
OPTIMEDICA CATALYS PRECISION LASER SYSTEM
K113479
Optimedica Corporation
Ophthalmic · 28d
Cleared Nov 22, 2011
FEMTEC LASER SYSTEM FOR CAPSULOTOMY
K110427
Technolas Perfect Vision GmbH
Ophthalmic · 281d
Cleared Oct 19, 2011
TBD
K112098
Lensar, Inc.
Ophthalmic · 89d