Dr. Pen M8 Review

The Dr. Pen M8 is a cheap, capable-looking home microneedling pen with a weak paper trail. It has no FDA clearance, Health Canada named it in a 2021 advisory telling people not to buy or use Dr. Pen pens, and its own seller gives two different answers on whether you need to sterilize the cartridges yourself. Dr. Pen US sells it for $199 with a one-year warranty, and its 16-pin cartridges cost $55 for ten. If you want a Dr. Pen with an FDA record behind it, that is the A20, a different pen sold for professional use. This review is based on documented evidence: nobody at this site has used the device.

Health Canada named the M8 by model

On December 16, 2021, Health Canada published “Advisory – Dr. pen microneedling devices are not authorized for sale and may pose health risks”. It covers the “Dr. pen Auto Microneedle System. All models, including but not limited to, A1, A6, A7, A6S, E30, M5, M7, M8, N2 and X5, and Ultima versions.”

The advisory says “Dr. pen microneedling pens and cartridges are not licensed by Health Canada” and that “to date, no microneedling devices have been authorized for at-home use, where there are higher health risks associated with inappropriate use, contamination, and infection.” It lists “infection, cross-contamination, pigmentation changes (patches of darker or lighter skin), reactivation of herpes cold sores, and swollen lymph nodes” as serious adverse events linked to microneedling devices in general. Its advice to consumers: “Do not use or buy unauthorized Dr. pen microneedling pens and cartridges.”

The advisory is about Canadian licensing, not a US ban. No document found for this review withdraws it or says the M8 has since been licensed in Canada. Our scoring rules treat an open regulator advisory as a hard cap on safety, so that cap applies here.

FDA status: no clearance for the M8

The M8 has no 510(k). The only Dr. Pen device in the FDA’s clearance records is the “Dr. pen Microneedling System”, K230420, cleared on August 11, 2023 for Guangzhou Ekai Electronic Technology Co., Ltd. It is a prescription device, cleared “to improve the appearance of facial acne scars in adults aged 22 years and older.” Dr. Pen US sells that pen as the A20 for $599.

The A20’s clearance does not carry over to the M8. The two pens differ on the points the FDA reviewed. The A20’s 510(k) summary describes a “sterile, single use microneedling cartridge” with 14 needles, a speed of “6300 – 7700” RPM and a 2.0 mm maximum depth. The M8 is sold with up to “15,000 RPM”, a 2.5 mm maximum and 16-pin cartridges. Our FDA lookup page explains how to check any pen, and clearance versus approval covers what a clearance does and does not mean.

Dr. Pen US does not claim FDA clearance for the M8. Its product page says “This product may not have been evaluated by the Food and Drug Administration”.

Who it’s for, and who it isn’t

For: people in the US who have already decided to microneedle at home, accept that no home pen is FDA-cleared, and want a low entry price with cartridges that are easy to buy.

Not for: anyone in Canada, where the regulator says not to buy or use it. Not for anyone who wants a pen with published depth-accuracy data, a clinical study or a cleared indication. The M8 has none of the three.

Specs

Figures are from the Dr. Pen US product page (checked 2026-10-06) unless marked otherwise.

	Dr. Pen M8
Speed	“Powerful motor up to 15,000 RPM”, “6-speed control”
Depth	“Adjustable needle depth from 0mm-2.5mm”
Display	“Built-in LED screen”
Power	“Rechargeable with a 4-hour battery life”; a reseller guide lists it as both wired and wireless
Default cartridge	16-pin, “the finest needle gauge, at 0.18mm in thickness” (cartridge page)
Other cartridges sold	11-pin, 36-pin and nano, all $55 per 10
Cartridge fit	“M8 cartridges are exclusively compatible with the Dr. Pen M8”
In the box	Pen, “2x Round Nano-pin Cartridges”, US charger adapter, USB cable, manual, travel case
Warranty	12 months
Price	$199 (Dr. Pen US); $89.99 (originaldrpen.com)

Two things in that table need a closer look. The box ships with nano cartridges only: “Microneedling cartridges will need to be purchased separately if required.” So a first-time buyer pays for at least one pack before the pen can microneedle at all. And Dr. Pen US sells a charger for the M8 in two versions, “M8-DC Port” and “M8-Type C”, which suggests more than one hardware revision under the same name.

The depth dial sets how far the needles extend from the cartridge. It does not say how deep they go into skin, and no depth-accuracy measurement for the M8 has been published. Owners ask about this too:

Owners of the M8 from Dr. Pen, can you adjust the length of the needles?
byu/Gloomy-Speaker-1999 inMicroneedling

That thread asks whether M8 owners can adjust the length, and the snippet’s reply says the depth “is adjustable from 0 to I think 2 or 2.5. The pen is adjustable, not necessarily the needle.”

Sterile or not? The seller gives two answers

This is the most useful thing to know before buying. Dr. Pen US’s M8 product page says: “Microneedling/Nano-needling cartridges must be sterilized before each use to ensure safe and hygienic treatment.” It then describes soaking the needle in “isopropyl alcohol solution (70% or above)” for “a couple of minutes”.

The same company’s page for the M8’s 16-pin cartridges says the opposite: “Dr. Pen cartridges arrive in individually sealed, sterile pouches, sterilized with ethylene oxide gas and UV light during packaging. Secondary sterilization with isopropyl alcohol before use is entirely optional.”

Both pages agree on disposal: “Safely dispose of cartridges after every use”, and do not use “One cartridge more than once.” An instruction to sterilize a cartridge yourself before each use only makes sense for a cartridge that gets reused, which both pages forbid.

A second question is backflow, where serum or fluid runs back up into the pen body. A reseller’s model guide lists anti-backflow cartridges for “the A11, A8S, A9, and M8S” and does not include the M8. Dr. Pen US does not say either way for the M8’s cartridges, so this is unverified.

What owners report

Dr. Pen US shows 361 reviews on its M8 page. Those sit on the seller’s own site, so they are not independent evidence. The independent record is thin and anecdotal.

Dermapen M8 cartridge
byu/Alternative_Emu2947 inMicroneedling

That thread is titled “Dermapen M8 cartridge”, and the snippet Google shows for it includes the lines “My Dr. Pen M8 broke. I disassembled it and in my opinion it was not made for daily use.” One owner’s broken pen is not a failure rate, and no public data gives one.

An FDA MAUDE search on October 6, 2026 found two adverse-event reports with Dr. Pen in the brand name, neither naming the M8. A 2021 report lists models “A8, A6, A6S, A7” and its narrative opens with “INFECTION”. A 2023 report concerns an A6S whose reporter added water to the cartridge tip and found it “DRIPPED DOWN THE STEM OF TIP THAT INSERTED INTO THE DEVICE ITSELF”. MAUDE reports are unverified submissions and do not prove a device caused anything. A count this small says little about how often problems happen, since most users never file a report.

Buying a genuine M8

Several stores use the Dr. Pen name, and the prices spread widely: $199 at us.drpen.co, $89.99 at originaldrpen.com, and a Banggood search listing showing “Only US$44.99” for a “Dr. Pen Ultima M8” (search snippet only, not checked on the page). Dr. Pen US’s privacy policy names eShopping Group Pty Ltd of Welshpool, Western Australia as its operator. Which site, if any, is the manufacturer’s own US channel is unverified. The confusion shows up on Reddit:

Will the real Dr.Pen please stand up
byu/lederdaddy inMicroneedling

Titled “Will the real Dr.Pen please stand up”, it opens with the poster saying they “accidentally purchased a fake M8” from a website and only found out after contacting another seller.

Service, warranty and privacy

Dr. Pen US’s refund policy says its products “are eligible for repair or replacement for a period of 12 months from the original invoice date under warranty”, covering “component and manufacturing defects” and excluding “misuse, incorrect procedures, tampering, incorrect maintenance, physical damage or misadventures”. The site banner adds “lifetime support”, which is troubleshooting help rather than a longer warranty.

Returns are narrow. The policy offers “a 14-day Change of Mind return from the date of purchase, subject to a 20% restocking fee”, only for items “In new, unopened condition, including plastic wrap remaining sealed”, and “Return shipping in this case is at your expense.” So once the M8 is out of its wrap, a change of mind is not covered. Trustpilot refused our automated request (HTTP 403), so the company’s complaint record is unverified here.

The privacy policy (last updated 21 Nov 2025) is a standard Shopify template. It covers device, order and support information, says “We share information about your use of the Site, your purchases, and your interaction with our ads on other websites with our advertising partners”, and says data is “initially processed in Ireland” and then transferred to places including Canada and the United States. No privacy incident involving the store turned up.

Cartridges and running cost

Using this site’s standard schedule (one full-face session every 4 weeks, one new cartridge each time, 13 cartridges a year) and Dr. Pen US prices checked on October 6, 2026:

• 16-pin cartridges: $55.00 per pack of 10, so $5.50 each
• Cartridges for a year: 13 × $5.50 = $71.50
• First year: $199.00 (pen) + $71.50 = $270.50

Cartridges come in tens, so in practice 13 means buying two packs ($110.00) and holding seven spares for the next year. At the $89.99 originaldrpen.com price, the first year is $89.99 + $71.50 = $161.49, if its cartridges cost the same, which was not checked. Serum is extra: the instructions tell you to apply a hyaluronic acid serum before needling each area, and the store’s own (Peachaboo) costs $29.95 for 30 ml.

M8 or M8S?

The M8S is the newer pen, reviewed separately in our Dr. Pen M8S review. On Dr. Pen US it costs $299 against the M8’s $199, and its cartridges cost $59.95 per ten against $55.00. The reseller model guide lists the M8S as wireless only, 16,000 RPM and 18-pin by default, against the M8’s wired-and-wireless, 15,000 RPM and 16-pin. Cartridges do not swap between them. Dr. Pen US’s M8S page also calls it “For professional use only”, wording the M8 page does not use. Neither pen has an FDA clearance.

How it scored

• Safety (2): Health Canada’s 2021 advisory names the M8 and caps it at 3, and it loses a further point because the seller’s pen page tells buyers they “must” alcohol-soak cartridges while its cartridge page calls that “entirely optional”, and the M8 is missing from the reseller’s list of anti-backflow models.
• Build (5): The seller publishes speed, depth range and a 0.18 mm needle, but no depth-accuracy figure or drive description, and the only failure report found is one Reddit snippet, so the category gets the neutral score.
• Performance (7): A 0–2.5 mm range, six speeds up to 15,000 RPM, an LED display, battery or cable power and public instructions, though those instructions contradict each other on cartridge handling.
• Value (7): $199 for the pen plus 13 × $5.50 = $71.50 a year in cartridges makes $270.50 for the first year, a low cost of entry, held back by a box that ships without microneedling cartridges.
• Service (4): A 12-month warranty is short, change-of-mind returns require a sealed box, a 20% restocking fee and paid return shipping, and the complaint record could not be checked. The store’s refund and warranty terms are shared by every Dr. Pen model it sells, so they score the same on each review.
• Privacy (4): Dr. Pen US (us.drpen.co) uses one Shopify template privacy policy for every model: it shares data with advertising platforms and still contains an unfilled “[INSERT OTHER COOKIES OR TRACKING TECHNOLOGIES THAT YOU USE]” placeholder. No incident was found. The same policy gets the same score on every Dr. Pen review.
• Evidence (3): No 510(k), no published study of the M8 (PubMed’s only Dr. Pen study used the Ultima A1 on gums), and the product page shows uncited claims such as “90% Visible improvements in fine lines and wrinkles” while listing scarring, hair growth and stretch marks as targets.

Alternatives

• Dr. Pen M8S: the M8’s successor, $299 at Dr. Pen US, 18-pin cartridges, also named under the advisory’s “all models” wording and also uncleared.
• Dr. Pen A20: the one Dr. Pen pen with an FDA clearance (K230420), for prescription use on facial acne scars, at $599. It suits a clinic, not a bathroom shelf.
• Derminator 2: a home pen listed at “$ 149” with cartridges at “$ 2.85” and a “Lifetime warranty on manufacturing defects”, which its maker says uses a “Honeywell Hall sensor” to verify needle depth. It has no FDA clearance either.

FAQ

Is the Dr. Pen M8 FDA approved? No. It has no FDA clearance or approval. The only Dr. Pen device cleared by the FDA is the “Dr. pen Microneedling System” (K230420), sold as the A20 for prescription use.

Is the Dr. Pen M8 legal in Canada? Not as a licensed device. Health Canada’s December 2021 advisory says Dr. Pen pens and cartridges, M8 included, “are not licensed by Health Canada” and tells people not to buy or use them.

What cartridges does the Dr. Pen M8 use? M8-specific cartridges: 16-pin by default, with 11-pin, 36-pin and nano versions at $55 per ten from Dr. Pen US. The seller says they work only in the M8, so M8S or A6 cartridges will not fit.

How deep does the Dr. Pen M8 go? The dial runs from 0 to 2.5 mm, per Dr. Pen US. That is needle extension from the cartridge, and no measurement of actual penetration depth has been published.

Do Dr. Pen M8 cartridges need sterilizing? The seller contradicts itself. The pen page says cartridges “must be sterilized before each use” with alcohol; the cartridge page says they arrive sterile and the alcohol step is “entirely optional”. Both say to throw each cartridge away after one use.

Sources

• Dr. Pen US, Dr. Pen M8 Microneedling Pen (checked 2026-10-06): https://us.drpen.co/products/dr-pen-m8-microneedling-pen
• Dr. Pen US, 16 Pin Replacement Cartridges for M8 (checked 2026-10-06): https://us.drpen.co/products/16-pin-replacement-cartridges-for-m8-powerderm-10x
• Dr. Pen US, Dr. Pen M8S Microneedling Pen (checked 2026-10-06): https://us.drpen.co/products/dr-pen-m8s-microneedling-pen
• Dr. Pen US, Dr. Pen A20 Advanced Microneedling Pen (checked 2026-10-06): https://us.drpen.co/products/new-dr-pen-a20-advanced-miconeedling-pen
• Dr. Pen US, Full Range Chargers (checked 2026-10-06): https://us.drpen.co/products/dr-pen-full-range-chargers
• Dr. Pen US, refund policy (checked 2026-10-06): https://us.drpen.co/policies/refund-policy
• Dr. Pen US, privacy policy (last updated 21 Nov 2025, checked 2026-10-06): https://us.drpen.co/policies/privacy-policy
• Health Canada, “Advisory – Dr. pen microneedling devices are not authorized for sale and may pose health risks” (December 16, 2021): https://www.newswire.ca/news-releases/advisory-dr-pen-microneedling-devices-are-not-authorized-for-sale-and-may-pose-health-risks-898811970.html
• FDA 510(k) K230420, “Dr. pen Microneedling System”, decision letter and 510(k) summary: https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230420.pdf
• FDA 510(k) database entry for K230420: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K230420
• FDA MAUDE via openFDA, brand “dr pen” (searched 2026-10-06): https://api.fda.gov/device/event.json?search=device.brand_name:%22dr+pen%22&limit=100
• Dr. Pen Club, “Dr. Pen models” reseller guide (checked 2026-10-06): https://drpenclub.com/dr-pen-models/
• originaldrpen.com, “Dr. Pen M8 vs M8S” with price comparison (checked 2026-10-06): https://originaldrpen.com/dr-pen-m8-vs-m8s/
• Banggood search listing, “Dr. Pen Ultima M8” (search snippet only): https://usa-m.banggood.com/Dr_-Pen-Ultima-M8-Professional-Micro-Needling-Pen-with-Digital-Display-Adjustable-Needle-Length-0-0_3mm-Aluminum-Skin-Care-Beauty-Pen-Home-Use-Cordless-Device-2-x-16-Pin-Cartridges-Included-p-2005100.html
• Derminator 2 home page, specs, price and warranty (checked 2026-10-06): https://www.derminator.com/
• PMID 40161425: Microneedling Technique With Topical Vitamin C for Gingival Depigmentation Enhancing Gingival Aesthetics: A Longitudinal Study. Cureus, 2025.