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510(k) Data Aggregation

    K Number
    K201909
    Device Name
    RxSight Contact Lens
    Manufacturer
    RxSight, Inc.
    Date Cleared
    2020-09-10

    (63 days)

    Product Code
    HJK
    Regulation Number
    886.1385
    Why did this record match?
    Product Code :

    HJK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RxSight Contact Lens is indication and treatment in the anterior segment of the eye.
    Device Description
    The RxSight Contact Lens is a reusable diagnostic contact lens intended for intraocular visualization and therapy. The RxSight Contact Lens is used to maintain optical quality of the corneal surface and will provide lid stabilization to prevent blinking during therapeutic procedures that require magnification of the eye. The RxSight Contact Lens is designed around the classic diagnostic contact lens with similar design including an optical element with a specific magnification to provide excellent visualization. The optical component of the RxSight Contact Lens is made from polymethylmethacrylate (PMMA). The anodized aluminum cone houses the PMMA contact lens.
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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?
    Product Code :

    HJK

    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
    K151961
    Device Name
    Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens
    Manufacturer
    Volk Optical Inc.
    Date Cleared
    2015-08-18

    (33 days)

    Product Code
    HJK
    Regulation Number
    886.1385
    Why did this record match?
    Product Code :

    HJK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Volk Single-Use Contact Laser and Diagnostic Lenses (Direct Contact) are indicated for use as diagnostic lenses for eye fundus examinations and use in the therapy of intraocular abnormalities.
    Device Description
    The Volk Disposable Contact Laser and Diagnostic Lenses are a family of diagnostic and therapeutic contact lenses used for eye fundus examinations and therapy of intraocular abnormalities. The family consists of two (2) lenses, including the following: Iridotomy Lens and Capsulotomy Lens. The family of Volk Disposable Contact Laser and Diagnostic Lenses are designed around the classic Volk Contact Laser and Diagnostic Lenses. Each model lens is similar in design, but provide different optical elements to provide excellent visualization of the ocular anatomical areas for the particular intended use. The lenses are provided sterile for single use.
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    K Number
    K142715
    Device Name
    Sensor Medical Family of Vitrectomy Lenses and Products
    Manufacturer
    Sensor Medical Technology, LLC
    Date Cleared
    2014-12-16

    (85 days)

    Product Code
    HJK, HNR
    Regulation Number
    886.1385
    Why did this record match?
    Product Code :

    HJK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sensor Medical Family of Vitrectomy Lenses and Products allows visualization of the ocular fundus, vitreous and retinal structures during vitrectomy surgery.
    Device Description
    The Sensor Medical Family of Vitrectomy Lenses and Products includes single-use, disposable, sterile devices for use during vitrectomy surgery. The following devices are included in the family: Plano Lens, Magnifier Lens, Bi-Concave Lens, 20 degree Prism Lens, 30 degree Prism Lens, Osher 78 D Lens, Suture Ring, Silicone Ring, and Lens Forceps. The Sensor Medical Family of Vitrectomy Lenses and Products is designed around the classic Goldmann contact lens. Each style of lens is of similar design, with slight variations in the posterior surface shape to provide excellent visualization of the ocular anatomical areas for the particular intended use. When used in conjunction with an operating microscope, the ophthalmic lenses provide a binocular and stereoscopic view of the specific optical region of the eye. The lenses typically consist of a PMMA (acrylic) optical element that is applied for a short period of time directly on the globe or cornea of the eye.
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    K Number
    K051630
    Device Name
    SUPER VIEW DISPOSABLE BIOM LENS SET
    Manufacturer
    INSIGHT INSTRUMENTS, INC.
    Date Cleared
    2005-06-29

    (12 days)

    Product Code
    HJK
    Regulation Number
    886.1385
    Why did this record match?
    Product Code :

    HJK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Allow visualization of the ocular fundus, vitreous, and retinal structures during vitreoretinal surgery.
    Device Description
    The Super View Disposable BIOM Lens Set(s) consists of multiple sterile, disposable, thermoplastic lenses for both contact and non-contact use in conjunction with an operating microscope equipped with a BIOM wide-angle viewing system.
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    K Number
    K051103
    Device Name
    HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY
    Manufacturer
    HAAG-STREIT USA, INC.
    Date Cleared
    2005-06-07

    (39 days)

    Product Code
    HJK
    Regulation Number
    886.1385
    Why did this record match?
    Product Code :

    HJK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Haag-Streit Contact Glasses are a family of diagnostic and therapeutic contact lenses used in the examination of the eye fundus, retina and irido-corneal angle, and for the laser therapy of intraocular abnormalities.
    Device Description
    The HS Contact Glasses is a family of diagnostic and therapeutic contact lenses used for eye examination and therapy of intraocular abnormalities. The HS Contact Glass family is designed around the classic Goldmann contact lenses. All HS Contact Glass models are of similar design, but provide different optical elements to provide excellent visualization of the ocular anatomical areas for the particular intended use. When used in conjunction with the HS 900 slit-lamp, the HS Contact Glasses provide a binocular and stereoscopic view of the specific optical region of the eye. The HS Contact Glass typically consists of an aluminum housing, one or more mirror elements and a carved of time directly on the globe or cornea of the eye. The HS contact glass family has two principal modes of use. Those used with laser radiation for therapy of ocular abnormalities. HS Contact Glasses used in diagnostic procedures are made of acrylic plastic (PMMA). These are doolgnou with slit-lamps, such as fundus, the vitreous and the may of HS diagnostic Contact Glasses have the Flaag Otreit Bookine by Goldmann: 59/ 66/ 73 degrees.
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    K Number
    K050623
    Device Name
    VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D
    Manufacturer
    VOLK OPTICAL, INC.
    Date Cleared
    2005-03-28

    (18 days)

    Product Code
    HJK
    Regulation Number
    886.1385
    Why did this record match?
    Product Code :

    HJK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The devices are indicated for use as diagnostic contact lenses for eye fundus examinations and use in the therapy of intraocular abnormalities. The devices are sterile, single use, disposable lens systems.
    Device Description
    The subject device is a diagnostic and therapeutic contact lens system used for eye fundus examination and therapy of intraocular abnormalities. The lens is one element made from PMMA (polymethylmethracryalate). The lens is a sterile, disposable, single use device.
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    K Number
    K033950
    Device Name
    DORC VITRECTOMY LENSES, MODEL 1284 SERIES
    Manufacturer
    DUTCH OPHTHALMIC RESEARCH CENTER (D.O.R.C.)
    Date Cleared
    2004-02-20

    (60 days)

    Product Code
    HJK
    Regulation Number
    886.1385
    Why did this record match?
    Product Code :

    HJK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vitrectomy Lenses are intended to be used in conjunction with an operating microscope as a surgical optic to improve visualization of the ocular fundus, vitreous and retinal structures. Vitrectomy lenses are indicated for use during vitreoretinal surgical procedures.
    Device Description
    D.O.R.C. Vitrectomy Lens includes a variety of designs both sterile, single use, disposable vitrectomy lenses, as well as vitrectomy lenses intended to be reused which are sold non-sterile.
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    K Number
    K030054
    Device Name
    DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES
    Manufacturer
    FCI OPHTHALMICS, INC.
    Date Cleared
    2003-02-26

    (51 days)

    Product Code
    HJK, HMX, HNN
    Regulation Number
    886.1385
    Why did this record match?
    Product Code :

    HJK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The disposable Vitrectorny Set is used in the context of vitrectorny procedures. The self-blocking infusion cannula with infusion tubing provides the saline solution or balanced saline solution throughout the procedure, ensuring that the eye retains its tonicity. No sutures are required. The knife is used for making a calibrated and non-leaking incision into which the self-blocking infusion cannula is inserted. The lens, used with microscope, facilitates visualization of the retina by canceling the corneal diopter. An edge, which has a frosted ring on its upper side to avoid edge glare effects, allows users to position and move the lens on the cornea with forceps.
    Device Description
    Not Found
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    K Number
    K023221
    Device Name
    CONTACT LASER & DIAGNOSTIC LENSES
    Manufacturer
    VOLK OPTICAL, INC.
    Date Cleared
    2002-10-11

    (14 days)

    Product Code
    HJK
    Regulation Number
    886.1385
    Why did this record match?
    Product Code :

    HJK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is indicated for use as a diagnostic contact lens for eye fundus examinations and use in the therapy of intraocular abnormalities.
    Device Description
    Not Found
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