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510(k) Data Aggregation

    K Number
    K252673

    Validate with FDA (Live)

    Device Name
    LacertaMatrix
    Date Cleared
    2025-12-22

    (119 days)

    Product Code
    Regulation Number
    N/A
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    LacertaMatrix is indicated for use in the management of the following wounds:

    • partial and full-thickness wounds
    • pressure ulcers
    • venous ulcers
    • diabetic ulcers
    • chronic vascular ulcers
    • tunneled / undermined wounds
    • surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence)
    • trauma wounds (abrasions, lacerations, partial thickness burns, and skin tears)
    • draining wounds
    Device Description

    LacertaMatrix is a single use, non-pyrogenic wound dressing intended for use in local management of full thickness and partial thickness wounds. LacertaMatrix includes alligator derived hyaluronic acid (HA). LacertaMatrix is provided sterile in various size offerings up to 100cm² in a dual pouch configuration for aseptic transfer. Following placement, LacertaMatrix is gradually broken down and resorbed over time (typically over a period of within 2 weeks), as new tissue forms in its place.

    This device is limited to only one-time application to the wound. This device can only be used once within 24 hours and should be completely remove by rinsing with PBS to remove any residual device. Second application is restricted. Please use other FDA cleared dressing.

    AI/ML Overview

    N/A

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