{"product_id":"dr-pen-m8s-professional-microneedling-pen-kit-20-cartridges1743464126363","title":"Motorized Microneedling Pen Kit with 20 Replacement Cartridges","description":"\u003cdiv class=\"ge-pdp\"\u003e\n\u003csection class=\"fw band t\"\u003e\n  \u003cdiv class=\"nar ctr\"\u003e\n    \u003cp class=\"eyebrow\"\u003eRead this before you buy\u003c\/p\u003e\n    \u003ch2\u003eA motorized microneedling pen, described plainly.\u003c\/h2\u003e\n    \u003cp class=\"lede\"\u003eThis is a battery-powered pen that drives a needle cartridge up and down against the skin. It has six motor speeds on an LED display, a needle-length wheel marked from 0 to 2.5 mm, USB-C charging and twenty replacement cartridges. That is the whole product. Everything below is what we can verify about it, and what we do not claim.\u003c\/p\u003e\n  \u003c\/div\u003e\n\u003c\/section\u003e\n\u003csection class=\"fw band\"\u003e\n  \u003cdiv class=\"nar\"\u003e\n    \u003cp class=\"eyebrow\"\u003eRegulatory status\u003c\/p\u003e\n    \u003ch2\u003eWhat the FDA position on this pen is.\u003c\/h2\u003e\n    \u003cp\u003eIn the United States, powered microneedling pens are regulated by the FDA as Class II medical devices under 21 CFR 878.4430, whether or not they are sold for cosmetic purposes. A pen with a motor and a needle-length dial is designed to reach living skin, and that design alone puts it inside the device definition in the FDA's 2020 microneedling guidance.\u003c\/p\u003e\n    \u003cp\u003eThe manufacturer whose mark appears on this unit holds one FDA clearance (K230420, August 2023). It covers a different model, the A20, and it is a prescription-use clearance limited to adults aged 22 and older. This listing is an M8S-type unit, which is not the cleared model. Gear Elevation holds no FDA clearance for this unit and is not an authorized retailer of the brand.\u003c\/p\u003e\n    \u003cp\u003eWe therefore make no claim that this pen treats, improves or prevents any skin condition, or that it changes the structure or function of your skin. Where an earlier version of this page said otherwise, that wording has been removed. Customer reviews shown on this page are individual opinions and are not claims made by Gear Elevation.\u003c\/p\u003e\n  \u003c\/div\u003e\n\u003c\/section\u003e\n\u003csection class=\"fw band t\"\u003e\n  \u003cdiv class=\"in\"\u003e\n    \u003cp class=\"eyebrow\"\u003eSpecifications we can verify from the unit\u003c\/p\u003e\n    \u003ch2\u003eWhat the hardware is.\u003c\/h2\u003e\n    \u003cdiv class=\"spec\"\u003e\n      \u003cdiv class=\"r\"\u003e\n\u003cdiv class=\"k\"\u003eDrive\u003c\/div\u003e\n\u003cdiv class=\"v\"\u003eMotorized reciprocating cartridge head, on\/off button\u003c\/div\u003e\n\u003c\/div\u003e\n      \u003cdiv class=\"r\"\u003e\n\u003cdiv class=\"k\"\u003eSpeed\u003c\/div\u003e\n\u003cdiv class=\"v\"\u003e6 levels, shown on the LED display\u003c\/div\u003e\n\u003c\/div\u003e\n      \u003cdiv class=\"r\"\u003e\n\u003cdiv class=\"k\"\u003eNeedle-length wheel\u003c\/div\u003e\n\u003cdiv class=\"v\"\u003eMarked 0 to 2.5 mm on the collar\u003c\/div\u003e\n\u003c\/div\u003e\n      \u003cdiv class=\"r\"\u003e\n\u003cdiv class=\"k\"\u003eCartridge mount\u003c\/div\u003e\n\u003cdiv class=\"v\"\u003eThree-slot bayonet fitting; twenty cartridges included\u003c\/div\u003e\n\u003c\/div\u003e\n      \u003cdiv class=\"r\"\u003e\n\u003cdiv class=\"k\"\u003ePower\u003c\/div\u003e\n\u003cdiv class=\"v\"\u003eBuilt-in rechargeable battery, USB-C port in the cap\u003c\/div\u003e\n\u003c\/div\u003e\n      \u003cdiv class=\"r\"\u003e\n\u003cdiv class=\"k\"\u003eBody\u003c\/div\u003e\n\u003cdiv class=\"v\"\u003eGray housing with a white hinged storage case\u003c\/div\u003e\n\u003c\/div\u003e\n      \u003cdiv class=\"r\"\u003e\n\u003cdiv class=\"k\"\u003eAge\u003c\/div\u003e\n\u003cdiv class=\"v\"\u003eAdults 22 and older only, matching the age limit on the manufacturer's cleared model\u003c\/div\u003e\n\u003c\/div\u003e\n    \u003c\/div\u003e\n  \u003c\/div\u003e\n\u003c\/section\u003e\n\u003csection class=\"fw band\"\u003e\n  \u003cdiv class=\"nar\"\u003e\n    \u003cp class=\"eyebrow\"\u003eBefore any use\u003c\/p\u003e\n    \u003ch2\u003eHygiene rules that are not optional.\u003c\/h2\u003e\n    \u003cul class=\"blist\"\u003e\n      \u003cli\u003e\n\u003cstrong\u003eOne person, one pen.\u003c\/strong\u003e Never share the pen or a cartridge with anyone else.\u003c\/li\u003e\n      \u003cli\u003e\n\u003cstrong\u003eOne cartridge, one session.\u003c\/strong\u003e Cartridges are single-use. Dispose of a used cartridge as a sharp; do not re-cap and reuse it.\u003c\/li\u003e\n      \u003cli\u003e\n\u003cstrong\u003eUnbroken skin only.\u003c\/strong\u003e Do not use on broken, irritated, sunburned or infected skin, over moles, or near the eyes.\u003c\/li\u003e\n      \u003cli\u003e\n\u003cstrong\u003eStop on any reaction.\u003c\/strong\u003e Bleeding that does not stop, swelling, spreading redness or signs of infection mean stop and see a clinician.\u003c\/li\u003e\n      \u003cli\u003e\n\u003cstrong\u003eTalk to a professional first.\u003c\/strong\u003e A licensed clinician can tell you whether a device like this is appropriate for you at all. This page cannot.\u003c\/li\u003e\n    \u003c\/ul\u003e\n  \u003c\/div\u003e\n\u003c\/section\u003e\n\u003csection class=\"fw band t tight\"\u003e\n  \u003cdiv class=\"nar\"\u003e\n    \u003cp class=\"eyebrow\"\u003eIn the box\u003c\/p\u003e\n    \u003cdiv class=\"kit\"\u003e\n\u003cdiv\u003e\n\u003cb\u003ePen\u003c\/b\u003eMotorized handpiece with LED display\u003c\/div\u003e\n\u003cdiv\u003e\n\u003cb\u003e20 cartridges\u003c\/b\u003eReplacement needle cartridges\u003c\/div\u003e\n\u003cdiv\u003e\n\u003cb\u003eStorage case\u003c\/b\u003eWhite hinged case, as pictured\u003c\/div\u003e\n\u003c\/div\u003e\n  \u003c\/div\u003e\n\u003c\/section\u003e\n\u003c\/div\u003e\n\u003cstyle\u003e\n.ge-pdp{--ink:#232838;--mut:#4A5064;--fnt:#79808F;--rule:#E2DFD8;--paper:#FAF8F4;--paper2:#F2EFE9;\n  --acc:#5C7285;--accd:#41586B;--ok:#2F6B4F;\n  --serif:Georgia,'Iowan Old Style','Times New Roman',serif;\n  --sans:-apple-system,BlinkMacSystemFont,'Segoe UI',Roboto,Helvetica,Arial,sans-serif;\n  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