Motorized Microneedling Pen Kit with 20 Replacement Cartridges
Motorized Microneedling Pen Kit with 20 Replacement Cartridges
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Read this before you buy
A motorized microneedling pen, described plainly.
This 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.
Regulatory status
What the FDA position on this pen is.
In 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.
The 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.
We 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.
Specifications we can verify from the unit
What the hardware is.
Before any use
Hygiene rules that are not optional.
- One person, one pen. Never share the pen or a cartridge with anyone else.
- One cartridge, one session. Cartridges are single-use. Dispose of a used cartridge as a sharp; do not re-cap and reuse it.
- Unbroken skin only. Do not use on broken, irritated, sunburned or infected skin, over moles, or near the eyes.
- Stop on any reaction. Bleeding that does not stop, swelling, spreading redness or signs of infection mean stop and see a clinician.
- Talk to a professional first. A licensed clinician can tell you whether a device like this is appropriate for you at all. This page cannot.
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