The CODE-X Automatic Micro Needle System is a motorized, AC-powered microneedling device designed to mechanically create microscopic channels in the epidermal and upper dermal layers of the skin for aesthetic use. The device delivers controlled microneedle penetration through a reciprocating needle cartridge driven by the motorized handpiece with embedded microprocessor control. The system consists of the following components: • Motorized handpiece (reusable) with adjustable needle depth control • Sterile, single-use disposable microneedle cartridges (12-pin and 14-pin, EO sterilized)
A hand-held, electrically-powered device intended to be used in combination with a micro-needle cartridge (which contains micro-needles) to create high-density minute skin punctures to stimulate tissue regeneration and improve the appearance of the skin as part of collagen induction therapy (CIT). It includes controls to allow for treatment adjustments (e.g., puncture depth, frequency); a disposable micro-needle cartridge may be included. It is intended for clinical use by a healthcare provider to treat stretch marks, acne scarring, hyperpigmentation, wrinkles, and/or hair loss; it is not intended for energy-based skin treatment. This is a reusable device.