Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K242056
    Device Name
    miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus
    Manufacturer
    BenQ Materials Corporation
    Date Cleared
    2025-04-17

    (276 days)

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

    BenQ Materials Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    **miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus** is indicated as daily wear soft contact lens for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity. Eye care professional may prescribe the lens for single-use disposable wear, or for daily wear with frequent replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. **miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus** is indicated as daily wear soft contact lens for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity. The color lens may enhance or alter the apparent color of the eye. Eye care professional may prescribe the lens for single-use disposable wear, or for daily wear with frequent replacement. When prescribed for frequent replacement, the lens may be disinfected using a chemical disinfection system only. **miacare (miafilcon B) DELiGHT 1-Day Contact Lens with EautraSil Plus** are designed for daily wear as single-use soft contact lenses for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity. Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required. **miacare (miafilcon B) CONFiDENCE 1-Day Color Contact Lens with EautraSil Plus** are designed for daily wear as single-use soft contact lenses for correcting refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have refractive astigmatism of 1.00D or less, as long as the astigmatism does not impact visual acuity. The lenses may enhance or alter the apparent color of the eye. Eye care practitioners may prescribe the lens for daily wear (disposable use) single use. The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.
    Device Description
    **miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus and Miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus** - They are daily wear soft contact lens for frequent replacement - They are in a spherical lens design with UV blocker. - They are available in hemispherical shell. - The lens material is a silicon combination hydrogel. It is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer. - The water content is 46%. - A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% (2.31%) in the UVB range of 280-315nm and less than 50% (12.05%) in the UVA range of 316-380nm. - The miacare (miafilcon A) DELiGHT Contact Lens with EautraSil Plus" is a light blue tinted with "reactive Blue19" for handling visibility purpose. - The Miacare (miafilcon A) CONFiDENCE Color Contact Lens with EautraSil Plus is a color lens that may enhance or alter the apparent color of the eye. - The lens is supplied in a sterile state, packaged in a buffered saline solution. **miacare (miafilcon B) DELiGHT 1-Day Contact Lens with EautraSil Plus and miacare (miafilcon B) CONFiDENCE 1-Day Color Contact Lens with EautraSil Plus** - They are daily wear soft contact lens for daily disposable - They are in a spherical lens desing with UV blocker. - They are available in hemispherical shell. - The lens material is a silicon combination hydrogel. It is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer. - The water content is 48%. - A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% (2.36%) in the UVB range of 280-315nm and less than 50% (13.43%) in the UVA range of 316-380nm. - The miacare (miafilcon B) DELiGHT 1-day Contact Lens with EautraSil Plus" is a light blue tinted with "reactive Blue19" for handling visibility purpose. - The Miacare (miafilcon B) CONFiDENCE 1-day Color Contact Lens with EautraSil Plus is a color lens that may enhance or alter the apparent color of the eye. - The lens is supplied in a sterile state, packaged in a buffered saline solution.
    Ask a Question
    K Number
    K193185
    Device Name
    Anscare SIMO Negative Pressure Wound Therapy (NPWT) System
    Manufacturer
    BenQ Materials Corporation
    Date Cleared
    2020-05-04

    (168 days)

    Product Code
    OKO
    Regulation Number
    878.4683
    Why did this record match?
    Applicant Name (Manufacturer) :

    BenQ Materials Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SIMO System is indicated for patients who would benefit from a suction device (negative pressure wound therapy) as it may promote wound healing via removal of excess exudate and infectious materials. SIMO System is suitable for use in both hospital and homecare setting and is indicated for the following wound types: - Chronic wounds - Acute wounds - Traumatic wounds - Subacute and dehisced wounds - Partial-thickness burns - Ulcers (such as diabetic or pressure) - Flaps and grafts - Closed surgical incisions
    Device Description
    Anscare SIMO Negative Pressure Wound Therapy (NPWT) System including non-sterilized SIMO Pump and sterilized SIMO Dressing. Patient is able to carry the SIMO Pump easily in the pocket or a belt holder (additional accessory). Anscare SIMO Negative Pressure Wound Therapy (NPWT) System is also called "SIMO System" in the following description. SIMO System has 3 types of model variants including "2 SIMO Dressings and 1 SIMO Pump", "2 SIMO Dressings and 1 SIMO Pump with 1 holder" and "3 SIMO Dressings". Each type has 4 models, and each modelcontains 4 different sizes of SIMO dressing separately. SIMO System is for single person use only. SIMO Pump could use for 30 days. The SIMO Dressing is sterilized by Ethylene Oxide and single-use. SIMO System including non-sterilized negative pump and sterilize dressing. The negative pressure wound therapy is provided by a pump (-125±15mmHg) up to 30 days by manual and may promote wound healing via the removal of exudate. The negative pressure is provided by the SIMO Pump, and the exudates of wound bed is managed by the dressing. SIMO Dressing is applied to the wound. It should be changed in line with standard wound management guidelines, typically every 3-4 days up to 7 days. More frequent dressing changes may be required depending on the level of exudates, condition of the dressing, wound type/size, orientation of dressing, environmental considerations and/or other patient the considerations.
    Ask a Question
    K Number
    K150963
    Device Name
    AnsCare ChitoClot Pad
    Manufacturer
    BENQ MATERIALS CORPORATION
    Date Cleared
    2015-11-05

    (209 days)

    Product Code
    QSY, FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BENQ MATERIALS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AnsCare ChitoClot Pad is indicated for use of bleeding wound management. It promotes rapid control of wound bleeding and exudates absorption. AnsCare ChitoClot Pad is indicated for use in wound management and to provide barrier to bacteria. It is indicated for the following wounds, including lacerations, abrasions, hemodialysis wound and puncture sites for vascular procedures.
    Device Description
    AnsCare ChitoClot Pad is made from cross-linked chitosan with glutaraldehyde. It works as a topical wound dressing intended to promote hemostasis when in contact with a bleeding wound. AnsCare ChitoClot Pad is made from chitosan whose hemostatic effect is independent of anticoagulant. Chitosan has a long clinical history of safety and effectiveness.
    Ask a Question
    K Number
    K143462
    Device Name
    AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)
    Manufacturer
    BENQ MATERIALS CORPORATION
    Date Cleared
    2015-05-08

    (155 days)

    Product Code
    QSY, FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BENQ MATERIALS CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AnsCare ChitoClot Gauze (prescription use): For use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions, lacerations. AnsCare ChitoClot Gauze (over-the-counter use): To control bleeding of lacerations, minor cuts and abrasions.
    Device Description
    The AnsCare ChitoClot Gauze is made of a non-woven fabric derived from chitosan fibers. The device is made of 100% chitosan - it is not coated or impregnated with chitosan granules. Chitosan is a naturally occurring polysaccharide usually derived from shellfish, and its hemostatic properties are widely recognized in the biomedical field. When applied directly on a wound with firm pressure, the AnsCare ChitoClot Gauze will turn into a gel-like condition to absorb the blood and seal the wound. The AnsCare ChitoClot Gauze also contains acetic acid as an acidity regulator and Polysorbate 20 as a surfactant.
    Ask a Question

    Page 1 of 1