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510(k) Data Aggregation

    K Number
    K202038
    Device Name
    CryoTreQ
    Manufacturer
    VitreQ B.V.
    Date Cleared
    2020-12-30

    (160 days)

    Product Code
    HPS, CLA
    Regulation Number
    886.4170
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VitreQ CryoTreQ is indicated for use in ophthalmic surgery for retinal detachment, cyclodestructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, cryodestruction of lash follicles for trichiasis and the treatment of retinopathy of prematurity (ROP).
    Device Description
    The VitreQ CryoTreQ is a disposable, handheld instrument intended for use in ophthalmic cryotherapy. The device tip is made of stainless steel. The device utilizes a pressurized cryogen which is circulated to the tip. The cryogenic material remains enclosed within the tip during application, serving to cool the metal tip during therapy. Rapid gas expansion in the tip causes freezing to the Joule-Thompson principle.
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    K Number
    K200911
    Device Name
    MIRA Adapter
    Manufacturer
    Phakos
    Date Cleared
    2020-06-02

    (57 days)

    Product Code
    HRN
    Regulation Number
    886.4170
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PHAKOS Disposable Retinal Cryo Probe and Accessories is for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, and cryo destruction of lash follicles for trichiasis.
    Device Description
    The cryoprobe ADAPTER is a mechanical accessory used to adapt the PHAKOS Disposable Retinal Cryo Probe to different cryosurgery generators found on the market; it is connected to the cryoprobe connector on the generator. The rear end piece receiving the cryoprobe is the same for all ADAPTERs; the body varies according to the generator used. The ADAPTER is fitted on the generator in the place of the original cryoprobe, and remains in position, while the PHAKOS Disposable Retinal Cryo Probe is plugged into the universal rear end piece.
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    K Number
    K180195
    Device Name
    Frigitronics adapter
    Manufacturer
    Phakos
    Date Cleared
    2018-03-16

    (51 days)

    Product Code
    HRN
    Regulation Number
    886.4170
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PHAKOS Disposable Retinal Cryo Probe and Accessories is for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, and cryo destruction of lash follicles for trichiasis.
    Device Description
    The cryoprobe adapter is a mechanical accessory used to adapt the PHAKOS Disposable Retinal Cryo Probe to different cryosurgery generators found on the market; it is connected to the cryoprobe connector on the generator. The rear end piece receiving the cryoprobe is the same for all adapters; the body varies according to the generator used. The adapter is fitted on the generator in the place of the original cryoprobe, and remains in position, while the PHAKOS Disposable Retinal Cryo Probe is plugged into the universal rear end piece.
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    K Number
    K162756
    Device Name
    PHAKOS Disposable Retinal Cryo Probe
    Manufacturer
    PHAKOS
    Date Cleared
    2017-05-03

    (215 days)

    Product Code
    HRN
    Regulation Number
    886.4170
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PHAKOS Disposable Retinal Cryo Probe is for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataraction, and cryo destruction of lash follicles for trichiasis.
    Device Description
    The PHAKOS Disposable Retinal Cryo Probe is a single use item used with cryopexy equipment. It produces an ice ball at the tip of the pencil allowing you to treat the detachment of the retina by welding the tissues together. The ice ball is the result of a specific gas released at a high pressure, N2O or CO2, allowing the welding of the tissues by burn.
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    K Number
    K160591
    Device Name
    D.O.R.C. Disposable Cryo Probe
    Manufacturer
    DUTCH OPHTHALMIC RESEARCH CENTER INTERNATIONAL BV
    Date Cleared
    2017-01-23

    (328 days)

    Product Code
    HRN
    Regulation Number
    886.4170
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The D.O.R.C. Disposable Cryo Probe is intended for use in combination with the Cryostar Cryosurgical System to perform ophthalmic surgery of the posterior segments including cryopexy for retinal detachment, glaucoma, cataract extraction, trichiasis, and retionopathy of prematurity.
    Device Description
    The D.O.R.C. Disposable Cryo Probe is a single-use, handheld medical device intended for use in combination with the Cryostar Cryosurgical System to perform ophthalmic surgery. When the foot pedal of the CryoStar Console is pressed, high pressure gas (CO2 or N2O) is supplied via a small aperture to target tissue.
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    K Number
    K131787
    Device Name
    CRYOMATIC MKII CONSOLE, CRYOMATIC MKII PROBES, DISPOSABLE CRYO PROBES
    Manufacturer
    KEELER LTD.
    Date Cleared
    2013-12-23

    (188 days)

    Product Code
    HRN, REV
    Regulation Number
    886.4170
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Keeler Cryomatic System and probes are for use in ophthalmic surgery such as cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, cryo destruction of lash follicles for trichiasis and treatment of retinopathy of prematurity (ROP).
    Device Description
    The Cryomatic MKII console is a self-contained system. The console consists of a rigid PU enclosure, housing the principle subsystems, switch mode power supply, controller PCB and pneumatic control module. On the front of the console is an LCD screen and membrane key panel. The console provides the connection point for the range of probe (reusable and disposable), footswitch, mains electricity, gas supply and scavenging system. There is a variety of Keeler Re-usable Cryomatic Probes whose stainless tips are shaped depending on surgical application. The plastic handle is permanently connected to flexible pressure hose and integral connector, which connects to Cryomatic MKII Console. The Keeler Disposable Cryo Probe comprises a stainless steel stem with a metal handle connected to a 2m long bi-lumen high-pressure plastic hose contained within a protective outer tube and terminated with a customdesigned plastic connector for insertion into the Cryomatic MKII console.
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    K Number
    K062412
    Device Name
    CRYOMATIC
    Manufacturer
    KEELER INSTRUMENTS, INC.
    Date Cleared
    2006-11-06

    (81 days)

    Product Code
    HRN
    Regulation Number
    886.4170
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Keeler Cryomatic System and probes are for use in ophthalmic surgery in cryopexy procedures in refractory glaucoma, for retinal detachment, cryo destruction, cataract extraction, cryo destruction of lash follicles, extraction of fragments within the eye, and treatment of retinopathy of prematurity (ROP).
    Device Description
    Cryomatic System and Probes comprising of: a) Cryomatic Console b) Cryomatic Probes
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    K Number
    K012821
    Device Name
    D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM
    Manufacturer
    DUTCH OPHTHALMIC USA, INC.
    Date Cleared
    2001-10-22

    (60 days)

    Product Code
    HRN
    Regulation Number
    886.4170
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The D.O.R.C. Harmony CryoStar Cryosurgical System is a surgical system for ophthalmic surgery intended for use in surgery of the posterior segment or anterior segment including cryopexy for retinal detachment, glaucoma, cataract extraction, trichiasis, and retinopathy of prematurity.
    Device Description
    The D.O.R.C. CryoStar Cryosurgical System consists of a cryogen gas bottle, a console, an ophthalmic probe, a footswitch and necessary interconnections. The console controls delivery of the gas to the probe. It also processes signals from the footswitch, enabling the probe to freeze and defrost.
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    K Number
    K992954
    Device Name
    KEELER CRYO MASTER & PROBES
    Manufacturer
    KEELER INSTRUMENTS, INC.
    Date Cleared
    1999-12-21

    (111 days)

    Product Code
    HRN
    Regulation Number
    886.4170
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    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Keeler CryoMaster & Probes are for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, cryo destruction of lash follicles for trichiasis, and treatment of retinopathy of prematurity (ROP).
    Device Description
    Not Found
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