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510(k) Data Aggregation

    K Number
    K170591
    Device Name
    Altomed Malhotra Platinum Segments
    Manufacturer
    Altomed Limited
    Date Cleared
    2017-06-06

    (98 days)

    Product Code
    MML
    Regulation Number
    886.5700
    Why did this record match?
    Applicant Name (Manufacturer) :

    Altomed Limited

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Malhotra Platinum Segments are eyelid implants designed for the gravity-assisted treatment of lagophthalmos.
    Device Description
    Sterile, single use, eyelid weight implant segments, used to treat Lagophthalmos to weigh down the upper eye lid to aid closure, used in combinations to achieve optimum result for each patient. The devices are made of 90% platinum 10% iridium, an industry standard alloy utilized for eyelid implants. The segments are rectangular in shape, contoured to the shape of the eye, with suture holes for both linking segments together in a chain and securing segments into position. Two sizes of segments are provided, with total weight customized for patient need by surgeon selection of segment combinations. The min/max combination range is from total 0.4g to total 2.0g. They achieve their intended purpose through gravity, weighing down the upper eyelid.
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