Microneedling Pens: Home Models vs Professional Devices
Electric microneedling pens come in two groups: devices that clinics use, and models sold to consumers. The FDA has cleared some pens for professional use, and it says it has not authorized any microneedling device for over-the-counter sale. Read each page for who the maker says a pen is meant for.
Last reviewed:
What an electric pen is
The FDA describes the device type as a powered microneedle pen with a single-use needle cartridge and a multi-use motorized base, used on skin, face and body (1). The cartridge holds the needles. The base moves them quickly and, on many models, lets the user set how far they extend.
Consumer pens use a similar format. What differs is who the product is meant for, what the maker has told the FDA and what you have to do yourself: set the depth, handle the cartridge and keep it clean.
What the FDA database shows
- Class 2 device type, product code QAI, 21 CFR 878.4430 (1).
- SkinPen Precision System, De Novo DEN160029, March 1, 2018, a prescription device for facial acne scars in adults aged 22 and older (2).
- SkinPen Precision Elite System, 510(k) K241400, August 29, 2024, prescription use (3).
- A "Dr. pen Microneedling System," 510(k) K230420, decision August 11, 2023. The summary lists the indication as facial acne scars in adults aged 22 and older and the use as prescription use (4).
A caution on names. The seller pages below name their pens M9 and M8 Max. The FDA entry above is named "Dr. pen Microneedling System." From the database we cannot tell whether that entry covers any of these retail models. Ask the seller for the 510(k) number and the intended-use statement that applies to the exact model, and who it is meant for. We do not decide the regulatory status of any product.
The FDA says it has not authorized any microneedling medical device for over-the-counter sale (5).
Two pens, as one seller describes them
Figures are the seller's own and may change. We did not test these products and we do not rank them. Both pens come from one seller's catalogue, so this comparison is limited and says nothing about other makers. A model its seller labels for professional use only is outside this comparison.
| Dr. Pen M9 | Dr. Pen M8 Max | |
|---|---|---|
| Who it is for, per the page | The page does not say it is for professionals only | The page calls it designed for an easier at-home routine |
| Needle depth | Adjustable 0 to 2.5 mm in 0.2 mm steps, with a one-click switch | Adjustable 0 to 2.5 mm; the timer does not change depth or speed |
| Speed and motor | 6 speed levels, up to 7,700 RPM | Speed set manually |
| Cartridges | Chip recognizes genuine cartridges; the page says cartridges arrive in sterile pouches | Chip cartridge recognition, with status on the display |
| Extras | Pen stand, USB-C charging | Timer modes of 15, 20 or 25 minutes; stand that pauses the pen automatically; wide LED display; USB-C charging |
| What the page says about the FDA | Nothing about the FDA in the text we read | Says the product may not have been evaluated by the TGA or the FDA. It names no FDA entry number |
| Source | (6) | (7) |
The two pages frame their pens differently, so ask the seller to state in writing who each model is meant for.
Product names appear in plain text. This page has no purchase links, and the figures come from the makers' own pages, read on October 15, 2026.
Cartridges and hygiene
The FDA says re-using cartridges can cause or spread infection, and that a product for home use should be cleaned between uses as directed and never shared (5). A cartridge touches broken skin each time it is used, so treat each one as single-use.
Who should leave pens to professionals
Anyone who is unsure about depth. A pen set to 2.5 mm is working far deeper than the 0.25 mm figure on the roller pages. The FDA recommends a provider specially trained in microneedling, because needles can reach nerves and blood vessels (5). The risks and who should check first are listed in the aftercare guide.
Common questions
Can I buy a professional microneedling pen?
What needle depth is used on the face?
Sources
- FDA product classification database, product code QAI (checked October 15, 2026)
- FDA De Novo database, DEN160029 (checked October 15, 2026)
- FDA 510(k) database, K241400 (checked October 15, 2026)
- FDA 510(k) database, K230420 (checked October 15, 2026)
- FDA consumer update on microneedling devices (content current as of 10/15/2025; checked October 15, 2026)
- Seller page: Dr. Pen M9 (captured October 15, 2026)
- Seller page: Dr. Pen M8 Max (captured October 15, 2026)