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510(k) Data Aggregation

    K Number
    K242184
    Device Name
    Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);
    Manufacturer
    Alcon Laboratories Inc.
    Date Cleared
    2024-12-04

    (132 days)

    Product Code
    MPA
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Alcon Laboratories Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Alcon 27GA Chandelier The 27GA Chandelier is indicated for use during posterior segment ophthalmic surgery. Alcon 27+ DS Wide Angle Endoilluminator The 27+DS Wide-Angle Endoilluminator is indicated for use during posterior segment ophthalmic surgery. Alcon 27+ DS Endoilluminator The 27 + DS Endoilluminator is indicated for use during posterior segment ophthalmic surgery.
    Device Description
    As part of this premarket notification Alcon presents three new endoilluminators, compatible with the UNITY VCS device cleared in K233876 (clearance date: June 21, 2024). Alcon 27GA Chandelier: The Alcon 27GA Chandelier provides a hands-free wide field of illumination for vitreoretinal procedures. The distal end of the device incorporates a short, tapered fiber optic to provide wide angle illumination projected from a pars plana position of the eye. The distal end consists of a tapered fiber, which is inserted into the eye through the Alcon 27GA entry system. The fiber is malleable so the physician can shape it to form a stable service loop, position the tip, and minimize interference with the lid speculum. Alcon 27+ DS Wide Angle Endoilluminator: The Alcon 27+ DS WA Endoilluminator offers wide-angle illumination, featuring a sapphire lens at the distal end of the probe. This design ensures consistent, low-glare illumination across a broad field of view. Additionally, it incorporates a Dynamic Stiffener (DS) element-a retractable stiffener designed to minimize needle deflection at the proximal end of the stainless steel cannula. as opposed to the fixed stiffener used in previous models. Alcon 27+ DS Endoilluminator: The Alcon 27+ DS Endoilluminator transmits light energy into the eye and incorporates a DS element at the proximal end of the stainless-steel cannula.
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    K Number
    K233876
    Device Name
    UNITY VCS (8065000296); UNITY CS (8065000297)
    Manufacturer
    Alcon Laboratories Inc.
    Date Cleared
    2024-06-21

    (197 days)

    Product Code
    HQC, HQE, HQF
    Regulation Number
    886.4670
    Why did this record match?
    Applicant Name (Manufacturer) :

    Alcon Laboratories Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    UNITY VCS: The UNITY VCS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) and posterior segment (i.e. vitreoretinal) ophthalmic surgery. In addition, with the optional laser this system is indicated for photocoagulation (i.e. vitreoretinal and macular pathologies), iridotomy, and trabeculoplasty procedures. UNITY CS: The UNITY CS console, when used with compatible devices, is indicated for use during anterior segment (i.e. phacoemulsification and removal of cataracts) ophthalmic surgery.
    Device Description
    The UNITY VCS is a multifunctional surgical instrument for use in anterior and posterior segment ophthalmic surgeries. The capabilities of the UNITY VCS include driving a variety of handpieces that provide the ability to cut vitreous and tissues, emulsify the crystalline lens, illuminate the posterior segment of the eye, and apply diathermy to stop bleeding. Flow-controlled or vacuumcontrolled aspiration is used to remove ocular matter from the eye. Pressure-controlled irrigation/infusion capability is provided to replace fluid in the eye and enters the eye directly through either an infusion cannula or a handpiece. The graphical user interface is menu-driven. The operator provides inputs using the touchscreen panel, the remote control, and the foot controllers. An optional, fully integrated laser module is available that can be installed in the base of the UNITY VCS configuration for vitreoretinal surgery. The laser delivers the same visible 532-nm green treatment beam designed for ophthalmic use as in the predicate device. When used with compatible components and accessories, the system will perform anterior and posterior segment ophthalmic procedures, including irrigation, phacoemulsification, extraction, vitrectomy, diathermy coagulation, intraocular illumination, photocoagulation, viscous fluid control, tissue grabbing and cutting. The UNITY CS is a multifunctional surgical instrument for use in anterior segment ophthalmic surgeries. The capabilities of the UNITY CS include driving a variety of handpieces that provide the ability to cut anterior vitreous and tissues, emulsify the crystalline lens, and apply diathermy to stop bleeding. Flow-controlled or pressure-controlled aspiration is used to remove ocular matter from the eye. Pressure-controlled irrigation/infusion capability is provided to replace fluid in the eye and enters the eye directly through either an infusion cannula or a handpiece. The graphical user interface is menu-driven, and the operator provides inputs using the touchscreen panel, the remote control, and the foot controllers. When used with compatible components and accessories, the system will perform anterior segment ophthalmic procedures, including irrigation, phacoemulsification, extraction, vitrectomy, and diathermy coagulation. The UNITY VCS and UNITY CS are intended to be used within a clinic(s)/hospital(s)/surgical practice network. Both devices are for prescription use only.
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    K Number
    K210436
    Device Name
    Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere
    Manufacturer
    Alcon Laboratories Inc.
    Date Cleared
    2021-04-12

    (59 days)

    Product Code
    LPL, MVN
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    Alcon Laboratories Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TOTAL30™ (lehfilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity. TOTAL30™ Asphere (lehfilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters of astigmatism that does not interfere with visual acuity. TOTAL30™ for Astigmatism (lehfilcon A) toric soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes with up to 6.00 diopters (D) of astigmatism. TOTAL30™ Multifocal (lehfilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity. TOTAL30™ Multifocal Toric (lehfilcon A) soft contact lenses are indicated for the optical correction of presbyopia with or without refractive ametropia (myopia and byperopia) in phakic persons with non-diseased eves who may require a reading addition of +3.00 diopters (D) or less and who may have up to 6.00 diopters (D) of astigmatism. The lenses are to be prescribed for daily wear, with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion, or disposal, as recommended by the eve care professional. Lenses should be discarded with a new pair each month, or more often, if recommended by the eye care professional.
    Device Description
    The subject device, TOTAL30™ (lehfilcon A) soft contact lenses, are made from a surface treated, silicone containing hydrogel lens material that is approximately 55% water and 45% lehfilcon A. The color additive Reactive Blue 247 is added to the lens material to create a light blue-green edgeto-edge color to make it easier to see when handling. The lenses contain two benzotriazole monomers to block UVA and UVB radiation and, additionally, reduce transmittance in the range from 380 nm to 450 nm. Lehfilcon A represents a Group 5B silicone hydrogel contact lens material ("enhanced oxygen permeable materials') according to ISO 18369-1:2017, Ophthalmic optics - Contact lenses - Part 1: Vocabulary, classification system and recommendations for labelling specifications, as follows: Group Suffix: 5B Hydrogel Material: High water subgroup Description: A subgroup of Group 5 which contains more than 50 % water and no ionic monomer or oligomer at pH 6 to pH 8 Lehfilcon A lens designs include spherical, asphere, toric, multifocal toric contact lenses in the following parameter ranges: Diameter Range: 13.0 to 15.0 mm Base Curve Range: 8.0 to 9.2 mm Power Range: -20.00 D to +20.00 D Center Thickness: varies with design and power (Example: 0.08 mm for -3.00 D spherical) Cylinder Power (Toric) -0.25 D to -10.00 D ADD Power (Multifocal) LO, MED, HI Lenses have the following properties: Refractive index: 1.40 (hydrated) Water content: 55% by weight in normal saline Surface water content: ≥ 90% Oxygen permeability: 123 x 10 -11 [(cm2/sec)(ml O2 /ml.mmHg)] measured at 35 °C (normalized Dk-Polarographic method) Light transmittance: >85% UV Transmittance: The transmittance characteristics are less than 1% in the UVB range of 280 nm to 315 nm and less than 10% in the UVA range of 315 to 380 nm for the entire power range. Lehfilcon A contact lenses are supplied sterile in sealed blister packs containing isotonic phosphate buffered saline solution (PBS) with polymeric wetting agents.
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