FDA.reportPublic FDA data

General/multiple surgical diode laser system

Definition
An electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.
GUDID devices
129
Last updated
2025-04-01 13:23:20

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
02816901023677Typenex MedicalWeinert Fiber Optics, Inc.NV06342025-03-24
00860004755982InnoVoyce VYLO LaserInnovoyce LLCA2025-02-07
00860011812104InnoVoyce VYLO Eye Safety Filter ZeissInnovoyce LLCA2025-02-07
00860011812111InnoVoyce VYLO FootswitchInnovoyce LLCA2025-02-07
00860011812180InnoVoyce VYLO CartInnovoyce LLCA2025-02-07
06971858366256SLTJiangxi Medex Technology Co., Ltd.SFE 0.6-SMA2024-12-24
08800022301404VeincareWONTECH CO.,LTDVeincare2024-12-17
02816901023660Typenex MedicalWeinert Fiber Optics, Inc.NV06322024-11-03
00850067051008Promoitalia LaserPromoitalia LLCiLaser 19402024-10-31
00813125010249Eye Safety Filter, Fixed (532 nm) IRIDEX CORPORATION307752024-10-22
00813125010256Eye Safety Filter, Fixed (532 nm)IRIDEX CORPORATION312602024-10-22
00813125010263Eye Safety Filter, Two-Position (532 nm)IRIDEX CORPORATION304942024-10-22
00813125010270Eye Safety Filter, Two-Position (532 nm)IRIDEX CORPORATION304932024-10-22
00813125014490Eye Safety Filter, Two-Position (577 nm)IRIDEX CORPORATION654722024-10-22
00813125014506Eye Safety Filter, Two-Position (577 nm)IRIDEX CORPORATION654732024-10-22
00813125014513Eye Safety Filter, Two-Position (532 nm)IRIDEX CORPORATION654742024-10-22
00813125014520Eye Safety Filter, Two-Position (532 nm)IRIDEX CORPORATION654752024-10-22
00813125015039Eye Safety Filter, Fixed (577 nm)IRIDEX CORPORATION655512024-10-22
00813125017149Eye Safety Filter, Fixed (532 nm) IRIDEX CORPORATION303672024-10-22
00813125017163Eye Safety Filter, Fixed (577 nm)IRIDEX CORPORATION654702024-10-22
00813125017170Eye Safety Filter, Fixed (577 nm) IRIDEX CORPORATION654712024-10-22
00813125010188Eye Safety Filter, Fixed (810 nm)IRIDEX CORPORATION131072024-10-21
00813125010195Eye Safety Filter, Fixed (810 nm)IRIDEX CORPORATION140802024-10-21
00813125017118Eye Safety Filter, Fixed (810 nm) IRIDEX CORPORATION103782024-10-21
00813125017125Eye Safety Filter, Fixed (810 nm) IRIDEX CORPORATION111752024-10-21
00813125017132Eye Safety Filter, Fixed (532 nm) IRIDEX CORPORATION303662024-10-21
00813125017156Eye Safety Filter, Fixed (532 nm)IRIDEX CORPORATION303642024-10-21
00860012392605ORskinLAUNCH DEVELOPMENT CORPORATIONORskin Blue 4452024-08-20
06976492570335TriangelTRIANGEL RSD LIMITEDST-AR2024-08-12
00763000521370VISUALASEMEDTRONIC NAVIGATION, INC.97355422024-08-03
G650DIOGO1XOD DioGo compact diode laserXOD Inc.DIOGO12024-07-10
06974624060112PIOONWuhan Pioon Technology Co., Ltd.M22024-06-28
00813125010584OMA (810 nm)IRIDEX CORPORATION134112024-05-06
00813125010591OMA (810 nm)IRIDEX CORPORATION116712024-05-06
00813125010645OMA (810 nm)IRIDEX CORPORATION116722024-05-06
00813125016975SLA EasyView™ (577 nm)IRIDEX CORPORATION656212024-05-06
00813125016999SLA (577 nm)IRIDEX CORPORATION656222024-05-06
00813125017019SLA (532 nm)IRIDEX CORPORATION655052024-05-06
00813125010935SLA (810 nm)IRIDEX CORPORATION127752024-05-02
00813125011147SLA EasyFit™ (532 nm)IRIDEX CORPORATION30898-Z3S2024-05-02
00813125011185SLA 50 µm (532 nm)IRIDEX CORPORATION31172-022024-05-02
00813125011208SLA 50 µm (532 nm)IRIDEX CORPORATION31174-022024-05-02
00813125016524SLA EasyView™ (532 nm)IRIDEX CORPORATION655042024-05-02
00813125016548SLA (810 nm)IRIDEX CORPORATION108422024-05-02
00813125016982SLA Standard (577 nm)IRIDEX CORPORATION655122024-05-02
00813125017002SLA Standard (532 nm)IRIDEX CORPORATION655112024-05-02
08059340290000Primo Dental LaserMEDENCY SRLPrimo2024-04-10
08059340290017Primo Dental LaserMEDENCY SRLPrimo2024-04-10
08059340290024Primo Dental LaserMEDENCY SRLPrimo Komfort2024-04-10
08059340290031Primo Dental LaserMEDENCY SRLPrimo Lite2024-04-10
08059340290048Primo Dental LaserMEDENCY SRLPrimo Blue2024-04-10
08059340290055Primo Dental LaserMEDENCY SRLPrimo Triplo2024-04-10
08059340290062Primo Dental LaserMEDENCY SRLPrimo Triplo2024-04-10
08059340290079Primo Dental LaserMEDENCY SRLPrimo Triplo2024-04-10
06974624060129PIOONWuhan Pioon Technology Co., Ltd.S1Pro2024-01-23
00813125015381Iridex 577 LaserIRIDEX CORPORATION240002024-01-18
00813125015473Iridex 532 LaserIRIDEX CORPORATION230002024-01-18
15051684015134VenaCureANGIODYNAMICS, INC.VCURE1470/US2024-01-02
00860008944870NovilaseNovian Health Inc.LTS 2.1 (EU/Switzerland)2023-11-15
00860008944887NovilaseNovian Health Inc.LTS 2.1 (UK)2023-11-15
00860008944825NovilaseNovian Health Inc.LTS 2.1 (USA)2023-11-12
06971858360162SLTJiangxi Medex Technology Co., Ltd.SACSll2023-11-10
08057017760689DEKA PHYSIQ 360DEKA M.E.L.A. SRLM134A12023-10-11
E2352171B1DentaLaze KitSHOFU DENTAL CORPORATIONDL0012023-06-06
02816901022564Typenex MedicalWeinert Fiber Optics, Inc.NV06342021-05-28
07290110122881LipoSense 150mm 3mm Mercedes Cannula with Temp Sensor & HandleALMA LASERS LTD.12023-02-06
07290110122898LipoSense 260mm 3mm Mercedes Cannula with Temp Sensor & HandleALMA LASERS LTD.12023-02-06
01816901023470Typenex MedicalLEONI FIBER OPTICS, INC.NV06332023-02-03
01816901023708Typenex MedicalLEONI FIBER OPTICS, INC.NV06352023-02-03
06971858363927LaserProJiangxi Medex Technology Co., Ltd.LaserPro 9802022-11-17
17340007000611Mobile Laser UnitClinical Laserthermia Systems AB1001-022022-10-28
17340007000826Mobile Laser UnitClinical Laserthermia Systems AB1001-N22022-10-28
17340007000871Instructions for use Tranberg Thermoguide Therapy System - USClinical Laserthermia Systems ABL-2019-0622022-10-28
37340007000653Tissue Temp ProbeClinical Laserthermia Systems AB3001-012022-10-28
37340007000660Tissue Temp ProbeClinical Laserthermia Systems AB3001-022022-10-28
37340007000677Tissue Temp ProbeClinical Laserthermia Systems AB3002-012022-10-28
37340007000684Tissue Temp ProbeClinical Laserthermia Systems AB3002-022022-10-28
37340007000691Tissue Temp ProbeClinical Laserthermia Systems AB3003-012022-10-28
37340007000707Tissue Temp ProbeClinical Laserthermia Systems AB3003-022022-10-28
37340007000714Tissue Temp ProbeClinical Laserthermia Systems AB3004-012022-10-28