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The DP4 microneedling device 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, IV and V in adults aged 22 years or older.

DP4 Microneedling device is a Digital Automated Microneedling system. The DP4 system consists of the following components: - 1. Handpiece - 2. Needle Cartridge - 3. DP4 Sleeve (barrier sleeve) - 4. Battery Charger, 2 Batteries - 5. AC/DC Power Adaptor - 6. Desk Stand - 7. DP4 US™ companion app. The handpiece (1) contains a mains connector, a drive train, a digital display to relay information to the operator an ON/OFF button and 2 separate toggle buttons to adjust frequency and needle depth. The handpiece receives its power via an external AC/DC power adaptor (input Voltage/Current is 100-240VAC, 1.0-0.5A,50-60Hz: Output Voltage/Current: 5V DC, 2.4A) or removable lithium ion battery (3.7 VDC). The battery does not need to be removed to make use of the mains power adaptor. The power adaptor connects to the handpiece via a custom DC connection (over-mold bayonet type). The drive train encompasses a DC motor, eccentric cam and rotational to linear drive converter to oscillate the Cartridge needles. The digital display shows battery status, cartridge status, sync/update notifications and bluetooth connectivity. The display also contains a digital dial to convey frequency or motor speed and a 3figure display showing current needle depth. The frequency of oscillation can be set from 80-110Hz (+/-10 Hz(range 70-120Hz) and the needle depth from 0.2mm to 3mm. The DP4 needle Cartridge (2) is a sterile, single use consumable designed to create micro incisions in the epidermis and dermis. Each cartridge contains 16, 3mm, 33-gauge surgical grade stainless steel needles, arranged in a circular pattern. Each needle cartridge employs a bayonet feature to securely connect it to the handpiece during operation. Internal and external seals assist in the prevention of cross contamination. Each needle Cartridge contains a Radio-frequency identification (RFID) tag encoded with a unique ID and a needle depth correction factor. This information is read from the cartridge when it is first inserted into the handpiece and prevents reuse of the cartridge once the cartridge is removed from the handpiece. The DP4 sleeve (3) is a single use, sterile, biohazard barrier used to prevent contamination of the handpiece by bodily fluids generated during the treatment. It covers the extent of the handpiece, including the intersection between the handpiece and needle Cartridge. The battery charger (4) is capable of charging 1 x 14500 Lithium cell. The system batteries can only be charged when removed from the handpiece and inserted into the battery charger. The desk stand (5) is used for storage of device while not in use. The DP4 US companion app software application (6) is an app. run on a Bluetooth enabled User device to enable the User to interact with the DP4 CRM system. The app contains no patient data and transmits no patient data. The equipment is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat.