E-PEN (E-PEN)

The E-PEN is a rechargeable microneedling device that creates microscopic punctures in the skin using 14 reciprocating stainless steel needles. It is intended to treat facial acne scars in adults aged 22 and older by adjustable needle penetration depth, with a sterile single-use cartridge attached to a reusable pen body powered by a lithium-ion battery.

The E-PEN matches the predicate SkinPen Precision System across all critical parameters: 14 needles at 34 gauge, 6,300–7,700 RPM speed, 105–128 stamps/second puncture rate, 1.5 mm recommended penetration depth, stainless steel straight needles in radial arrangement, and ethylene oxide sterilization. Minor differences include a maximum needle depth setting of 2.0 mm (versus 2.5 mm) and slightly smaller hub surface area, neither affecting the standard 1.5 mm treatment depth.

ISO 10993 biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogen); ISO 11135, ISO 10993-7, ISO 11138, ISO 11737, ISO 11140, and AAMI TIR series for EO sterilization validation; ASTM D4169-22 for shipping simulation, ASTM F88/F88-15 for seal peel, ASTM F1929-15 for dye migration, ASTM F1980-21 for shelf-life acceleration; IEC 60601-1:2005+A1:2012 and EN/IEC 60601-1-2:2015 for electrical safety and EMC.

The E-PEN is substantially equivalent because it shares the same product code (QAI), identical indications for use (facial acne scars, adults ≥22 years), same needle count/gauge/material/arrangement, identical recommended treatment depth (1.5 mm), matching speed and puncture rate, and equivalent sterilization method as the predicate. The minor differences—lower maximum depth setting and slightly smaller hub—do not raise different safety or effectiveness questions since both devices recommend and clinically treat at 1.5 mm, and performance testing confirms equivalent safety and efficacy. The device includes appropriate precautions against depths exceeding 1.5 mm in user labeling.