Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K222199
    Device Name
    Collagen P.I.N. (Percutaneous Induction Needling)
    Manufacturer
    Induction Therapies LLC
    Date Cleared
    2022-10-21

    (91 days)

    Product Code
    QAI, OAI
    Regulation Number
    878.4430
    Why did this record match?
    Applicant Name (Manufacturer) :

    Induction Therapies LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Collagen P.I.N. (Percutaneous Induction Needling system is indicated for use as a treatment to improve the appearance of facial acne scars in adults with Fitzpatrick Skin Types I - III, aged 22 years and older.
    Device Description
    The Collagen P.I.N. consists of a handheld device that creates microinjuries into the skin, by virtue of a 1 A DC motor that rapidly reciprocates (7000 - 9000 rpm) an array of 35 gauge (SWG) stainless steel microneedles. The device handpiece motor body is comprised of aluminum alloy, with a dial mechanism that controls the depth of penetration of the microneedle array from 0.0 mm to a maximum of 3.0 mm. The Collagen P.I.N. disposable needle cartridge is designed in a single configuration - a 36-pin array in a radial arrangement. The needles, which are 3.0 mm long, are composed of medical grade stainless steel, with a 1.0 mm conical taper to needle array is housed in a cartridge housing that prevents liquids from entering the handpiece motor body via the inside lumen of the cartridge. The needle cartridge is composed of a polycarbonate outer shell and piston, which houses the microneedle array. The microneedle array is attached to the polycarbonate shell using a silicone boot, which acts as spring mechanism which facilitates the microneedling mode of action. Each lot of disposable microneedle cartridges are individually packaged and sterilized by ethylene oxide gas ("EtO"). The device contains a rechargeable lithium-ion battery. The device is to be operated only cordlessly, and not used while the device is plugged into the wall charging station.
    Ask a Question

    Page 1 of 1