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The SER Pen Carain MicroSystem is intended 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 and as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older.

The SER Pen Carain MicroSystem (MP1209SP) is a handheld device that creates channels as well as microinjuries into the skin, by virtue of a DC motor drive system that rapidly reciprocates an array of 12 needles and 36 needles that are no longer than 2.5mm. The device consists of a power source, a motor body with depth adjustment, and a disposable, single use cartridge containing an array of needles. The power source consists of a rechargeable lithium-ion battery that delivers no more than 5 volts DC and 1 amp of current to power the motor. A power cord connects the wall adaptor to the device via a USB connector and a standard 1/8" headphone plug on the device side. The motor body is comprised of anodized aluminum with a dial mechanism that controls the depth of penetration of the microneedles from 0.0 mm to a maximum of 2.5mm. The SER Pen Carain MicroSystem's disposable cartridge is designed in two configurations, a 12-needle array and a 36-needle array. The needle array is housed in a specially designed cartridge housing with a silicon spring that prevents liquids from entering the motor body via the inside lumen of the cartridge. The SER Pen Carain MicroSystem biolock sleeve is a one end elastic opening PE bag to protect the whole system from cross contamination from the outside during the operation procedure. The SER Pen Carain MicroSystem microneedles are composed of 304 18/8 surgical steel tested and certified as biocompatible under GLP testing conditions that conform to ISO 10993-5, 10993-10, and 10993-11. A metallurgical analysis under GLP testing conditions that conform to ASTM E1019-11(Method A)(C/S Analyzer) was also completed and is attached. Each lot of cartridges are individually packaged and then gamma ray sterilized by TUV Sud accredited facility under procedure code P1501314 with a minimum dose of 25kGy. Certifications on file with the Sponsor and available for review.