FDA.report

Ophthalmic solid-state laser system

Definition
An electrically-powered device assembly with a solid-state laser (exited glass/crystal rod), that might be designed to optionally utilize the diode pump laser as a direct therapeutic laser, intended for ophthalmic surgery (e.g., photocoagulation, photodisruption) and/or photostimulation of retinal pigment epithelium (RPE) cells to reverse macular degeneration. It might include a built-in slit lamp, a dosimetry sensor, and/or frequency doubling technology, however it does not include femtosecond pulsing or fundus imaging technology.
GUDID devices
35
Last updated
2025-11-25 07:55:59

Related Product Codes

CodeDeviceSpecialtyClassDevices
HQFLaser, OphthalmicOphthalmic229
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery25
HQBPhotocoagulator And AccessoriesOphthalmic21

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
03830074980000MR Q supineMeridian Medical d.o.o.MR Q supine2025-10-20
03830074980017MR Q Meridian Medical d.o.o.MR Q 2025-10-20
03830074980024MR Q SLTMeridian Medical d.o.o.MR Q SLT s, MR Q SLT c2025-10-20
03830074980048Merilas Meridian Medical d.o.o.Merilas 532 alpha, Merilas 532 / 577 / 810 shortpu2025-10-20
07290018686058Voyager DSLTBELKIN VISION LTD4308406102025-07-16
03700542625958CAPSULOQUANTEL MEDICALCAPSULO2025-03-25
09342395000038UltraQELLEX MEDICAL PTY LTDLQP3106-U2016-09-24
09342395000069SoloELLEX MEDICAL PTY LTDLT5106-S2016-09-24
09342395000113TangoELLEX MEDICAL PTY LTDLT5106-T2016-09-23
09342395000137UltraQELLEX MEDICAL PTY LTDLQP3106-U 2016-09-24
07290018686027Eagle BELKIN VISION LTD4208400102024-07-31
00810096330000Selecta Duet™Lumenis Be, Inc.Selecta Duet™2023-05-12
00810096330017Digital Duet™Lumenis Be, Inc.Digital Duet™2023-05-12
00810096330024Smart-V Illumination Add-onLumenis Be, Inc.Smart-V Illumination Add-on2023-05-12
09342395002209Tango Reflex NeoELLEX MEDICAL PTY LTDTango Reflex Neo2023-05-01
09342395002216Tango NeoELLEX MEDICAL PTY LTDTango Neo2023-05-01
09342395002223UltraQ Reflex NeoELLEX MEDICAL PTY LTDUltraQ Reflex Neo2023-05-01
00810096330062Smart532Lumenis Be, Inc.NA2023-04-02
00810096330345LaserLink SLumenis Be, Inc.NA2023-04-02
VS012027127ga Curved Laser ProbeVortex Surgical, Inc.VS0120.272020-01-29
07290109143637Smart-V Illumination Add-onLUMENIS INC.Smart-V Illumination Add-on2022-03-23
03700542625569VITRA 2 QUANTEL MEDICALVITRA 2 2021-12-29
03700542625613VITRA 810QUANTEL MEDICALVITRA 8102021-12-29
00813125015503PASCAL Synthesis, 577nmIRIDEX CORPORATIONPASCAL Synthesis 5772021-12-05
00813125015527PASCAL Synthesis, 532nmIRIDEX CORPORATIONPASCAL Synthesis 5322021-12-05
00813125015534PASCAL Synthesis, 577nmIRIDEX CORPORATIONPASCAL Synthesis 5772021-12-05
00813125015589PASCAL Synthesis TwinStar (577nm/638nm)IRIDEX CORPORATIONPASCAL Synthesis 577/6382021-12-05
00813125015596PASCAL Synthesis TwinStar (577nm/638nm)IRIDEX CORPORATIONPASCAL Synthesis 577/6382021-12-05
00813125016708PASCAL Synthesis, 532nmIRIDEX CORPORATIONSynthesis SLC & ESF 5322021-12-05
00813125016715PASCAL Synthesis, 577nmIRIDEX CORPORATIONSynthesis SLC & ESF 5772021-12-05
00813125016722PASCAL Synthesis, 532nmIRIDEX CORPORATIONSynthesis SLC & ESF 5322021-12-05
00813125016739PASCAL Synthesis, 577nmIRIDEX CORPORATIONSynthesis SLC & ESF 5772021-12-05
00813125016746PASCAL Synthesis, 532nmIRIDEX CORPORATIONSynthesis SLC & ESF 5322021-12-05
00813125016753PASCAL Synthesis, 577nmIRIDEX CORPORATIONSynthesis SLC & ESF 5772021-12-05
00813125016777PASCAL Synthesis, 577nmIRIDEX CORPORATIONPASCAL Synthesis 5772021-12-05