FDA.report

General/multiple surgical 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 general surgery and/or multiple specialized surgical applications (non-dedicated), which may include treatment of vascular diseases. It vaporizes/ablates soft tissue with moderate haemostasis, little charring, and a thin zone of necrosis. It includes a light source, delivery/positioning device(s), and controls/foot-switch and emits a midinfrared wavelength. It does not include frequency doubling technology.
GUDID devices
289
Last updated
2026-03-19 21:56:37

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Representative GUDID Devices

Primary DIBrandCompanyModelPublished
08034108512877TORODEKA M.E.L.A. SRLM136E12026-03-11
04250341904413SphinxLISA Laser Products GmbH103 001 0102026-01-23
04250341908596RevoLix and RevoLix Jr.LISA Laser Products GmbH105 105 3312026-01-23
04250341908695RevoLix DUOLISA Laser Products GmbH105 301 1112026-01-23
04250341910285Sphinx Jr.LISA Laser Products GmbH101 203 3112026-01-23
04250341910308Sphinx Jr. LISA Laser Products GmbH103 201 1112026-01-15
06974851085018BVLASERNanjing Bestview Laser S&T Co.,Ltd.Deluxlase2025-12-23
06974994310350tamburo Thulium Fiber Laser Systemmenovex Medical Technology (Shenzhen) Co., LtdMIL-TFL-600A2025-12-11
06974994310398tamburo Thulium Fiber Laser Systemmenovex Medical Technology (Shenzhen) Co., LtdMIL-TFL-600B2025-12-11
06974994310404tamburo Thulium Fiber Laser Systemmenovex Medical Technology (Shenzhen) Co., LtdMIL-TFL-600C2025-12-11
00810071230875Soltive GeminiIPG Medical CorporationMD2300F-0036822025-12-02
00810071230882Soltive GeminiIPG Medical CorporationMD2300F-0033022025-12-02
00810071230899Soltive GeminiIPG Medical CorporationMD2100F-0037052025-12-02
00810071231117LUROSIPG Medical CorporationMD2300F-0038712025-12-01
00810071231124LUROSIPG Medical CorporationMD2300F-0038722025-12-01
00810071231131LUROSIPG Medical CorporationMD2300F-0042082025-12-01
00810071231148LUROSIPG Medical CorporationMD2100F-0038692025-12-01
00810071231155LUROSIPG Medical CorporationMD2100F-0038702025-12-01
00810071231162LUROSIPG Medical CorporationMD2100F-003870D2025-12-01
04058784002655MultiPulse TFLAsclepion Laser Technologies GmbHJ19-8000-0002025-11-27
04058784002693MultiPulse TFLAsclepion Laser Technologies GmbHJ19-8100-0002025-11-27
08059173392186Litho EVOQUANTA SYSTEM SPAPVMS000642025-09-29
04049059301177CeramOptecCeramOptec GmbHLeonardo® Duster, Set2025-09-25
04049059519299CeramOptecCeramOptec GmbHLeonardo Duster ScopeSafe Fiber 150um, IC2025-09-25
04049059519305CeramOptecCeramOptec GmbHLeonardo® Duster ScopeSafe Fiber 200um, IC2025-09-25
04049059519312CeramOptecCeramOptec GmbHLeonardo® Duster ScopeSafe Fiber 272um, IC2025-09-25
04049059519329CeramOptecCeramOptec GmbHLeonardo® Duster ScopeSafe Fiber 365um, IC2025-09-25
04049059519336CeramOptecCeramOptec GmbHLeonardo® Duster ScopeSafe Fiber 550um, IC2025-09-25
04049059519343CeramOptecCeramOptec GmbHLeonardo® Duster ScopeSafe Fiber 800um, IC2025-09-25
04049059519350CeramOptecCeramOptec GmbHLeonardo® Duster ScopeSafe Fiber 1000um, IC2025-09-25
04049059519367CeramOptecCeramOptec GmbHLeonardo® Duster Fiber 200um Reusable, IC2025-09-25
04049059519374CeramOptecCeramOptec GmbHLeonardo® Duster Fiber 272um Reusable, IC2025-09-25
04049059519381CeramOptecCeramOptec GmbHLeonardo® Duster Fiber 365um Reusable, IC2025-09-25
04049059519398CeramOptecCeramOptec GmbHLeonardo® Duster Fiber 550um Reusable, IC2025-09-25
04049059519404CeramOptecCeramOptec GmbHLeonardo® Duster Fiber 800um Reusable, IC2025-09-25
04049059519411CeramOptecCeramOptec GmbHLeonardo® Duster Fiber 1000um Reusable, IC2025-09-25
03830054238176LightWalker MaxFOTONA d.o.o.M021-5AF/1 Max2025-07-11
07290109147161Lumenis Pulse 120HLUMENIS LTD.Lumenis Pulse 120H2022-09-18
07290109147178Lumenis Pulse 120HLUMENIS LTD.Lumenis Pulse 120H2022-09-18
07290109147185Lumenis Pulse, Moses 2.0 (DOM)LUMENIS LTD.Lumenis Pulse, Moses 2.0 (DOM)2022-09-18
07290109147192Lumenis Pulse 120HLUMENIS LTD.Lumenis Pulse 120H2022-09-18
07290109147208Lumenis Pulse, Moses 2.0 (INT)LUMENIS LTD.Lumenis Pulse, Moses 2.0 (INT)2022-09-18
07290109147215Lumenis Pulse 120HLUMENIS LTD.Lumenis Pulse 120H2022-09-18
07290109147222Lumenis Pulse 120HLUMENIS LTD.Lumenis Pulse 120H2022-09-18
07290109147291Lumenis Pulse 120HLUMENIS LTD.Lumenis Pulse 120H2022-09-18
07290109147307Lumenis Pulse 120HLUMENIS LTD.Lumenis Pulse 120H2022-09-18
00810071230837ThuveraIPG Medical CorporationMD2100F-001632R2024-12-05
00810071230844ThuveraIPG Medical CorporationMD2100F-001632H2024-12-05
00810071230851ThuveraIPG Medical CorporationMD2100F-001632D2024-12-05
00810071230141ThuveraIPG Medical CorporationMD2300F-0019602024-11-29
04049059301009CeramOptecCeramOptec GmbHLeonardo® DUAL 452024-11-15
04049059301092CeramOptecCeramOptec GmbHLeonardo® DUAL 2002024-11-15
00810071230134ThuveraIPG Medical CorporationMD2300F-0019522024-11-13
00810071230226ThuveraIPG Medical CorporationMD2300F-0015072024-11-13
00810071230820ThuveraIPG Medical CorporationMD2100F-0016322024-11-13
08800022301121NOUVADermWONTECH CO.,LTDNOUVADerm2024-10-04
03830054230866XPulseFOTONA d.o.o.1064 nm2022-12-21
04058784001986MultiPulse HoPLUSAsclepion Laser Technologies GmbHJ19-1191-0002024-06-25
08033945936938Laserlith I-dust QUANTA SYSTEM SPAPVMS000422017-05-04
04250341911695RevoLix HTLLISA Laser Products GmbH105 401 0102024-04-04
07290118853701Lumenis Pulse 60H, 60HzLUMENIS LTD.Lumenis Pulse 60H, 60Hz2023-12-10
00860004755951InnoVoyce Laser FiberInnovoyce LLCA2023-12-01
00860004755968InnoVoyce Laser FiberInnovoyce LLCA2023-12-01
00860004755975InnoVoyce Laser FiberInnovoyce LLCA2023-12-01
04049958004551Dornier ThulioDornier MedTech Laser GmbHK20160002023-01-27
08800022301107LavieenWONTECH CO.,LTDLavieen2023-09-20
08800022304016ALMA VEIL; V-LaserWONTECH CO.,LTDALMA VEIL; V-Laser2023-08-24
00855430006753OptiliteConvergent Laser TechnologiesOPT602023-06-07
M47321200Trimedyne® 2120 OmniPulse Mini™ Holmium Laser SystemTRIMEDYNE, INC.21202023-06-14
08033945937492Litho 60QUANTA SYSTEM SPAPVMS000492017-09-19
08033945938369Litho 100QUANTA SYSTEM SPAPVMS000552018-05-17
08800022303309Holinwon 30, HolinWON PrimaWONTECH CO.,LTDHolinwon 30, HolinWON Prima2020-06-16
08033945937515MH01QUANTA SYSTEM SPAPVMS000542017-10-09
08059173392278MultiLASE TFLQUANTA SYSTEM SPAUL6002022-11-28
07290109147055VersaPulse PowerSuite 80/100WLUMENIS LTD.VersaPulse PowerSuite 80/100W2022-09-19
07290109147062VersaPulse PowerSuite 80/100WLUMENIS LTD.VersaPulse PowerSuite 80/100W2022-09-19
07290109147079VersaPulse PowerSuite 100WLUMENIS LTD.VersaPulse PowerSuite 100W2022-09-19
07290109147086VersaPulse PowerSuite 100WLUMENIS LTD.VersaPulse PowerSuite 100W2022-09-19
07290109147093VersaPulse PowerSuite 60WLUMENIS LTD.VersaPulse PowerSuite 60W2022-09-19
07290109147154VersaPulse P20LUMENIS LTD.VERSAPULSE P202022-09-19