FDA.reportPublic FDA data

Femtosecond ophthalmic solid-state laser system

Definition
A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod to emit a high-power laser beam intended for ocular resections and incisions (cataract incisions, arcuate corneal/scleral cuts/tunnels, anterior capsulotomy, phacofragmentations, corneal flaps, lamellar/perforating keratoplasty). The system includes a beam delivery device, imaging device, computer, software and controls; it cuts by micro-photodisruption of tissue created by focused ultra-short [femtosecond (FS)] pulses; it does not include fundus imaging technology and the therapeutic laser is not frequency-doubled.
GUDID devices
38
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00380650009449LenSxAlcon Laboratories, Inc.80650009442025-10-01
00867744000105LENSAR LLS-fs 3DLENSAR, Inc.70-00005-0012016-09-24
00867744000112LENSAR LLS-fs 3DLENSAR, Inc.70-00013-0012016-09-24
00867744000150ALLYLENSAR, Inc.70-00050-0012023-08-18
04049471110135Treatment Pack (Size S)Carl Zeiss Meditec AG10132024-02-08
04049471110142Treatment Pack (Size M)Carl Zeiss Meditec AG10142024-02-09
04049471110159Treatment Pack (Size L)Carl Zeiss Meditec AG10152024-02-09
04049471110166Treatment Pack (Type KP)Carl Zeiss Meditec AG10162024-02-09
04049471095111VISUMAXCarl Zeiss Meditec AGVISUMAX 800 or 095112024-12-13
04049471100143Treatment Pack (Size M)Carl Zeiss Meditec AG10142024-02-09
04049471100150Treatment Pack (Size L)Carl Zeiss Meditec AG10152024-02-09
04049471100167Treatment Pack (Type KP)Carl Zeiss Meditec AG10162024-02-09
04049471100136Treatment Pack (Size S)Carl Zeiss Meditec AG10132024-02-08
10867744000157ALLYLENSAR, LLC70-00050-0012023-08-18
05050474738553ELITAJOHNSON & JOHNSON SURGICAL VISION, INC.EL20222023-08-11
07640167750573FEMTOSIE AG, Surgical Instrument EngineeringZ8 NEO2022-06-10
05050474709508CATALYS SYSTEMOPTIMEDICA CORPORATION0160-95002020-08-19
05050474617193CATALYS PATIENT CHAIRJOHNSON & JOHNSON SURGICAL VISION, INC.0160-60302020-08-01
05050474558557INTRALASE FS FEMTOSEC LASERJOHNSON & JOHNSON SURGICAL VISION, INC.J590114-0012019-11-04
04049471095036VisuMaxCarl Zeiss Meditec AGVisuMax2016-09-23
04049471110043Treatment Pack (Size S)Carl Zeiss Meditec AG1462-3322016-09-23
04049471110050Treatment Packs (Size M)Carl Zeiss Meditec AG1462-3332016-09-23
04049471110067Treatment Pack (Size L) Carl Zeiss Meditec AG1462-3342016-09-23
04049471110074Treatment Pack (KP)Carl Zeiss Meditec AG1523-1312016-09-23
04050555002895VICTUS™ Femtosecond Laser PlatformTechnolas Perfect Vision GmbH3.22016-09-24
05050474573451FS LASER SYSTEMJOHNSON & JOHNSON SURGICAL VISION, INC.20005D2016-09-02
05050474573468IFS ADVANCED FEMTOSEC LASERJOHNSON & JOHNSON SURGICAL VISION, INC.J20007D2016-09-02
05050474609792CATALYS SYSTEMOPTIMEDICA CORPORATIONCATALYS-U2016-09-02
05050474617186CATALYS SYSTEMJOHNSON & JOHNSON SURGICAL VISION, INC.CAT PREC LSR SYS2018-04-19
07640167750016FEMTOLDVSIE AG, Surgical Instrument EngineeringZ82016-09-15
07640167750023FEMTO LDVSIE AG, Surgical Instrument EngineeringZ62016-09-15
07640167750030FEMTO LDVSIE AG, Surgical Instrument EngineeringZ42016-09-15
07640167750047FEMTO LDVSIE AG, Surgical Instrument EngineeringZ22016-09-15
07640167750054FEMTO LDVSIE AG, Surgical Instrument Engineeringmed-profile2016-09-15
10867744000102LENSAR LLS-fs 3DLENSAR, LLC70-00005-0012016-09-24
10867744000119LENSAR LLS-fs 3DLENSAR, LLC70-00013-0012016-09-24
00380659909412WaveLightAlcon Laboratories, Inc.80659909412016-09-24
00380659981623LenSxAlcon Laboratories, Inc.80659981622016-09-24