PRO Pen Microneedling System (6883)

The PRO Pen Microneedling System is a handheld microneedling device with disposable 14-pin sterile cartridges intended to improve the appearance of facial acne scars in adults aged 22 years and older. It can be powered by rechargeable battery or AC adapter and uses single-use polymer and stainless steel needle cartridges.

The PRO Pen is identical to the predicate Dr. Pen device in indications for use, intended location, power source type, puncture rate, needle count/gauge, material, geometry, arrangement, spacing, sterilization, and cross-contamination protection. It differs by offering an alternate AC adapter power option, adjustable depth settings in 0.2mm increments up to 1.5mm maximum (versus predicate's 2.0mm), and 3-year cartridge shelf life (versus predicate's 2 years).

Not stated in this summary. The document references compliance with 21 CFR 878.4430 special controls but does not cite specific ISO, IEC, or ASTM consensus standards.

The PRO Pen shares identical indications for use, intended use location, primary mechanism of action, needle specifications, and material composition with the predicate. The differences—additional AC power option, lower maximum depth, and extended shelf life—do not affect the fundamental performance or safety profile. All required performance testing (needle depth accuracy, puncture rate, sterility, biocompatibility, EMC, cleaning validation) was successfully completed, demonstrating the device is as safe and effective as the predicate despite minor design variations.