FDA.reportPublic FDA data

Ophthalmic solid-state laser system, photodisruption

Definition
A mains electricity (AC-powered) device assembly in which input energy is used to excite a glass/crystal rod to emit a high-power laser beam intended to cause a photodisruptive effect in the eye by forming a plasma and generating mechanical shock waves (microexplosions) that destroy tissue when highly focused (e.g., for cataract extraction, posterior capsulotomy). It typically includes a light source and controls/foot-switch and has a built-in slit lamp biomicroscope, or is coupled to a slit lamp or indirect ophthalmoscope by fixed mirrors. It does not include femtosecond pulsing, frequency doubling, or fundus imaging technology.
GUDID devices
42
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
03700542625279OPTIMIS IIQUANTEL MEDICALOPTIMIS II2016-09-23
03700542625453SOLUTISQUANTEL MEDICALSLT2016-09-23
03700542625460OPTIMIS FUSIONQUANTEL MEDICALOPTIMIS FUSION2016-09-23
09342395000625EllexELLEX MEDICAL PTY LTD63357402016-09-24
09342395000663EllexELLEX MEDICAL PTY LTD63379952016-09-24
10809160209035AVID TruCustomAVID MEDICAL, INC.GVVA004-05_00032018-09-12
10809160209400AVID TruCustomAVID MEDICAL, INC.VAML020-07_00032018-09-13
10809160209882AVID TruCustomAVID MEDICAL, INC.VAOR023-01_00022018-09-18
10809160210062AVID TruCustomAVID MEDICAL, INC.VAOR023-01_00042018-09-20
00813125015497PASCAL Synthesis, 532nmIRIDEX CORPORATIONPASCAL Synthesis 5322021-10-14
00813125015602PASCAL Synthesis, 532nmIRIDEX CORPORATIONPASCAL Synthesis 532- PA042021-10-12
00813125016760PASCAL Synthesis, 532nmIRIDEX CORPORATIONPASCAL Synthesis 5322021-10-12
08631720003020AerolaseAEROLASE CORPORATIONErbiumXL2021-10-11
00813125016661PASCAL Synthesis, 577nmIRIDEX CORPORATIONPASCAL Synthesis 577- PA042021-09-25
04987669101452Ophthalmic YAG Laser SystemNIDEK CO.,LTD.YC-2002021-09-24
04987669101650YAG laser combination delivery unit (YC-200)NIDEK CO.,LTD.17148-K0202021-09-24
00086317200302AerolaseAEROLASE CORPORATIONErbium2019-12-02
00863172000304AerolaseAEROLASE CORPORATIONMicroPulse1064-XT2019-10-18
00855005006232PASCAL Synthesis TwinStarTOPCON MEDICAL LASER SYSTEMS, INC.PASCAL Synthesis TwinStar (577/638)- PA042019-09-17
00855005006249PACSAL SynthesisTOPCON MEDICAL LASER SYSTEMS, INC.PASCAL Synthesis 532- PA042019-09-17
00855005006256PASCAL SynthesisTOPCON MEDICAL LASER SYSTEMS, INC.PASCAL Synthesis 577- PA042019-09-17
00855005006263PASCAL Synthesis TwinStarTOPCON MEDICAL LASER SYSTEMS, INC.PASCAL Synthesis TwinStar (577/638)- PA042019-09-17
00855005006270PACSAL SynthesisTOPCON MEDICAL LASER SYSTEMS, INC.PASCAL Synthesis 532- PA042019-09-17
00855005006287PACSAL SynthesisTOPCON MEDICAL LASER SYSTEMS, INC.PASCAL Synthesis 577- PA042019-09-17
04049471091373VISULAS YAG IIICarl Zeiss Meditec AGVISULAS YAG III2016-09-20
04987669100073OPHTHALMIC YAG LASER SYSTEMNIDEK CO.,LTD.YC-18002016-06-24
00855005006003PASCAL SynthesisTOPCON MEDICAL LASER SYSTEMS, INC.PASCAL Synthesis 5322016-04-15
00855005006010PASCAL SynthesisTOPCON MEDICAL LASER SYSTEMS, INC.PASCAL Synthesis 5772016-04-15
00855005006027PASCAL SynthesisTOPCON MEDICAL LASER SYSTEMS, INC.PASCAL Synthesis 5322016-04-15
00855005006034PASCAL SynthesisTOPCON MEDICAL LASER SYSTEMS, INC.PASCAL Synthesis 5772016-04-15
00855005006041PASCAL SynthesisTOPCON MEDICAL LASER SYSTEMS, INC.Synthesis SLC & ESF 5322016-04-15
00855005006058PASCAL SynthesisTOPCON MEDICAL LASER SYSTEMS, INC.Synthesis SLC & ESF 5772016-04-15
00855005006065PASCAL SynthesisTOPCON MEDICAL LASER SYSTEMS, INC.Synthesis SLC & ESF 5322016-04-15
00855005006072PASCAL SynthesisTOPCON MEDICAL LASER SYSTEMS, INC.Synthesis SLC & ESF 5772016-04-15
00855005006089PASCAL SynthesisTOPCON MEDICAL LASER SYSTEMS, INC.Synthesis SLC & ESF 5322016-04-15
00855005006096PASCAL SynthesisTOPCON MEDICAL LASER SYSTEMS, INC.Synthesis SLC & ESF 5772016-04-15
00855005006157PASCAL SynthesisTOPCON MEDICAL LASER SYSTEMS, INC.PASCAL Synthesis 5322016-04-15
00855005006164PASCAL SynthesisTOPCON MEDICAL LASER SYSTEMS, INC.PASCAL Synthesis 5772016-04-15
00855005006171PASCAL Synthesis TwinStarTOPCON MEDICAL LASER SYSTEMS, INC.PASCAL Synthesis 577 /6382017-10-04
00855005006188PASCAL Synthesis TwinStarTOPCON MEDICAL LASER SYSTEMS, INC.PASCAL Synthesis 577 /6382017-10-04
00855005006195PASCAL SynthesisTOPCON MEDICAL LASER SYSTEMS, INC.PASCAL Synthesis 5322017-10-04
00855005006201PASCAL SynthesisTOPCON MEDICAL LASER SYSTEMS, INC.PASCAL Synthesis 5772017-10-04