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510(k) Data Aggregation

    K Number
    K200911
    Device Name
    MIRA Adapter
    Manufacturer
    Phakos
    Date Cleared
    2020-06-02

    (57 days)

    Product Code
    HRN
    Regulation Number
    886.4170
    Why did this record match?
    Applicant Name (Manufacturer) :

    Phakos

    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
    K173944
    Device Name
    Endocular Viewing Lenses and Silicone Ring
    Manufacturer
    Phakos
    Date Cleared
    2018-10-25

    (303 days)

    Product Code
    HJK
    Regulation Number
    886.1385
    Why did this record match?
    Applicant Name (Manufacturer) :

    Phakos

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ENDOCULAR VIEWING LENSES AND SILICONE RING family allows visualizations of the retina, the vireous humor, the lens, the iris, the anterior chamber, as well as other ocular structures during surgical procedures or consultation. The endocular viewing lens is a passive device that is used to view the fundus of the eye by placing it on the cornea.
    Device Description
    The "ENDOCULAR VIEWING LENSES AND SILICONE RING" family includes devices comprised of an endocular viewing lens and/or of a cornea support that allows for stabilization of this lens on the eye. This range allows one to view the retina, the vitreous humor, the lens, the iris, the angle of the anterior chamber, as well as other ocular structures during surgical procedures or consultation.
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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
    Why did this record match?
    Applicant Name (Manufacturer) :

    Phakos

    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
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHAKOS

    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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