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510(k) Data Aggregation

    K Number
    K253002

    Validate with FDA (Live)

    Device Name
    SkinStylus SteriLock MicroSystem (MP1209SL)
    Manufacturer
    Esthetic Medical, Inc.
    Date Cleared
    2026-02-19

    (153 days)

    Product Code
    QAI
    Regulation Number
    878.4430
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    34 - 120
    Reference & Predicate Devices
    K180778
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SkinStylus SteriLock® MicroSystem is a microneedling device and accessories intended to be used as a treatment to improve the appearance of periorbital wrinkles in Fitzpatrick skin types I, II, III, IV, V, and VI in adults aged 34 years or older.

    Device Description

    The SkinStylus SteriLock® MicroSystem (SSM) is a handheld microneedling device that uses an adjustable speed 5V 1A DC motor to rapidly reciprocate an array of 32-gauge microneedles that are no longer than 2.5 mm to create channels as well as microinjuries into the skin. The device consists of a power source, a motor body with depth adjustment, a removable nosecone interface, and a disposable, single-use, gamma ray sterilized cartridge, containing an array of microneedles.

    AI/ML Overview

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