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510(k) Data Aggregation

    K Number
    K233709
    Device Name
    Exceed Unlimited
    Manufacturer
    Mt.Derm GmbH
    Date Cleared
    2024-02-23

    (95 days)

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

    Mt.Derm GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Exceed Unlimited is a microneedling device and accessories intended for the treatment of wrinkles in Fitzpatrick skin types I. Il and/or III in the following facial areas: qlabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older. The Exceed Unlimited is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, III and IV in adults aged 22 years or older.
    Device Description
    The Exceed Unlimited device is intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainless steel needles. The Exceed Unlimited device consists of 7 component parts; Handpiece, sterile single use Safety needle cartridge, Handpiece holder, Barrier Sleeve, Battery, Charger incl. USB cable, power supply. The handpiece contains a motor that moves the needles. The handpiece receives power via a Li-Ion battery with an output of 3,7 V. The battery charger receives power from a standard 100-240V, 50-60Hz, 0.45A wall socket transformer with an USB output of 5 V, 3.2A. The frequency of the handpiece can be adjusted from 100-150Hz and is indicated on a display. The needle penetration is adjusted by the needle protrusion setting dial, which can be adjusted between 0.0 (min.) and 1.9 mm (max.). The standard safety needle cartridge (6-needle plate) contains 6 stainless steel microneedles of 1.5 mm length (0.35 mm gauge) and an internal safety membrane. The safety needle cartridge is screwed into the handpiece. The safety needle cartridge is sterile and for single use ONLY.
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    K Number
    K180778
    Device Name
    Exceed Microneedling Device
    Manufacturer
    MT.DERM GmbH
    Date Cleared
    2018-09-07

    (165 days)

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

    MT.DERM GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Exceed is a microneedling device and accessories is intended for the treatment of wrinkles in Fitzpatrick skintypes I, II and/or III in the following facial areas: glabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older.
    Device Description
    The Exceed micro needling device is intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainless-steel nicro needling device consists of 7 component parts; Control Unit, Sterile single use Safety needle cartridge, Handpiece holder, Handpiece cover, Footswitch, Power supply The control unit switches the device on and off and contains the power source (5.5-12 V, DC (150mA)). The control unit adjusts the frequency of the needle strom 100-150Hz using a digital display and a kevpad. The control unit receives power via a coaxial connector from a standard 100-240V, 50-60Hz, 1.2A wall socket transformer with an output of 15V. The handpiece contains a motor that moves the needles and a needle protrusion dial that allows the user to control the depth of the needle protrusion. The handpiece contains a scale that allows for the needle protrusion depth to be adjusted by the operator. The scale has a tolerance of +/-0.15 mm. The standard safety needle cartridge is a 6-stainless steel micro needle plate of 1.5 mm length. The safety needle cartridge is screwed into the handpiece. The safety needle cartridge is sterile and for single use only. This standard safety needle cartridge is used for microneedling only. The length of needles is 1.5 mm. In combination with the handpiece needle protrusion can be adjusted between 0.0 mm (min) and 1.5 mm (max).
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