Crown Aesthetics SkinPen Precision

SkinPen Precision is a cordless, battery powered microneedling pen built for clinical use. It reached the US market through FDA's De Novo pathway: Bellus Medical filed the request (DEN160029) in July 2016 and FDA granted it in March 2018, creating a new Class II regulation for microneedling devices for aesthetic use. The original grant covered treatment to improve the appearance of facial acne scars in adults 22 and older. Later 510(k) clearances under the Crown Aesthetics name, starting with K202243 in 2021, added neck wrinkles for Fitzpatrick skin types II to IV.

The system is a reusable handpiece with rechargeable lithium ion batteries, a charging base and a single use BioSheath barrier that covers the pen during treatment. Each treatment uses a sterile, single use needle cartridge with 14 stainless steel needles. The De Novo summary lists one motor speed of about 7,000 RPM, eleven depth settings from 0 to 2.5 mm in 0.25 mm steps, and a handpiece reliability rating of at least 2,000 hours of use. Treatment kits also include a hydrogel product called Lift HG.

The cartridge is proprietary and has a lock-out feature that stops a used cartridge from being installed a second time, so a pen is only usable with a supply of genuine SkinPen Precision cartridges. In 2024 Crown cleared the SkinPen Precision Elite (K241400), which adds an LCD screen and NFC chip authentication of cartridges in place of the original's manual lock-out and a plain on and off button. A pen with a display screen is the Elite rather than the Precision.

When selling a SkinPen Precision, list the number of handpieces and charging bases, the battery's condition and how long it holds a charge, and whether any unopened, in-date cartridges, sheaths or kits are included. Photos of the serial number on the pen and of the charging base help a buyer confirm the model and its age.