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510(k) Data Aggregation
K Number
K182407Device Name
Exceed Microneedling device
Manufacturer
Mt. Derm GmbH
Date Cleared
2019-07-19
(318 days)
Product Code
QAI
Regulation Number
878.4430Why 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 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 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 needles. The Exceed micro needling device consists of 7 component parts; Control Unit, Sterile single use Safety needle cartridge, Handpiece, 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 stroke from 100-150Hz using a digital display and a keypad. 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 gauge that allows the user to control the depth of the needle protrusion from 0 - 1.9mm. 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 a maximum of 1.5 mm.
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