Dermapen 4 Review
6.8/10 overall score for the Dermapen 4
Price: Not published; sold only to authorised clinics (checked 2026-10-06) · FDA status: FDA-cleared (K221070, as “DP4 Microneedling device”), prescription use · Last updated 2026-10-06
| Category | Weight | Score |
|---|---|---|
| Safety and regulatory status | 20% | 8/10 |
| Build and engineering | 15% | 8/10 |
| Performance and usability | 15% | 8/10 |
| Value | 15% | 5/10 |
| Customer service and warranty | 15% | 6/10 |
| Data privacy and seller conduct | 10% | 5/10 |
| Evidence and transparency | 10% | 6/10 |
The Dermapen 4 is a well-documented professional microneedling pen, and you can’t buy one for home use. The FDA cleared it in December 2022 under the name “DP4 Microneedling device” as a prescription device for facial acne scars, and DermapenWorld sells it only to clinics it has signed up as Authorised Treatment Providers. If you want Dermapen 4 results, you book a treatment with a trained provider. If you want a pen for your own bathroom, look at the Dermapen HOME or our other alternatives below. This review is based on documented evidence: nobody at this site has used the device.
A $70 “derma pen” is not a Dermapen 4
The word “dermapen” gets used for any electric microneedling pen. Among the top US results for that search, a store sells a Dr. Pen M5 Gold under the title “Dr. Pen Dermapen Rechargeable / With Plug”, and eBay lists “Derma Pen” devices at “$74.99” and “$66.99”. Neither is made by DermapenWorld. Reddit shows the same habit:
That thread is titled “Tips for micro needling with a Dermapen”, and its snippet shows the poster is using a “DR Pen m8”. DermapenWorld says its professional pen is “exclusively available to our Authorised Treatment Providers (ATPs)”, so a Dermapen 4 offered to the public by anyone else is not coming through that channel.
Who it’s for, and who it isn’t
For: licensed clinics and practitioners who treat acne scars and want a pen with an FDA clearance behind it, and patients choosing a clinic who want to know what the clinic’s pen is.
Not for: anyone planning to microneedle at home. DermapenWorld’s own FAQ says “Only a qualified practitioner may perform Dermapen clinical procedures under strict sterile conditions” and that “The professionals need to have a certificate to operate our device.”
Specs
All figures are from the FDA 510(k) summary for K221070 unless marked otherwise. In its comparison table the SkinPen Precision (the predicate device) is the left column and the DP4 is the right.
| Dermapen 4 (DP4) | |
|---|---|
| Needles | 16 per cartridge, “33-gauge surgical grade stainless steel”, circular pattern |
| Depth setting | “0.2mm – 3mm” |
| Maximum depth used in the clinical studies | 2.5 mm |
| Frequency | “80-110Hz (+/- 10 Hz)” |
| Drive | “DC motor, eccentric cam and rotational to linear drive converter” |
| Power | Mains adaptor or removable 3.7 V lithium-ion battery; can run on mains with the battery in |
| Cartridge | Sterile, single use, RFID tag that “prevents reuse of the cartridge once the cartridge is removed” |
| Barrier | Single-use sterile sleeve over the whole handpiece |
| App | “DP4 US” companion app over Bluetooth |
| Depth tolerance (bench test) | “+0.05mm / -0.4mm” |
| Warranty | 7 years per DermapenWorld’s US provider page (see Service, below) |
| Price | Not published |
The depth tolerance is worth reading closely. In porcine skin the needles went no more than 0.05 mm deeper than the setting, but up to 0.4 mm shallower, and the summary says needle extension at the maximum setting was “slightly below the maximum selectable depth”. So the pen errs toward going shallower than the setting, not deeper.
DermapenWorld also sells a second clinic pen, the Dermapen PRO, with “an adjustable depth of 0.2–1.5mm”. It isn’t the device in the FDA record.
FDA clearance: what it covers
In Canada, the Dermapen 4 is licensed: Health Canada’s device database lists “DERMAPENWORLD DERMAPEN4” under licence 106831, first issued October 13, 2021, with no end date (searched October 6, 2026).
The FDA record never uses the name Dermapen. It clears the “DP4 Microneedling device” (K221070), applicant Equipmed USA, LLC, decision date December 20, 2022, for prescription use. Its specifications (16 needles, 0.2–3 mm, a “DP4 US” companion app) match the Dermapen 4, and DermapenWorld’s FAQ cites “510(k) Number: K221070”. Equipmed USA’s Newport Beach address is also the registered office in DermapenWorld’s US privacy notice.
The cleared indication, quoted from the record:
“The DP4 microneedling device is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, III, IV and V in adults aged 22 years or older.”
Three limits follow from that. The clearance covers use by or under a licensed professional: the summary calls the DP4 “a prescriptive device intended to be used by physicians and suitably qualified personnel.” It covers one use, facial acne scars in adults 22 and over. And it stops at Fitzpatrick type V. Wrinkles, stretch marks, hair loss, rosacea and pigmentation all appear on DermapenWorld’s treatment pages, but none of them is in the cleared indication.
Two of the company’s own phrases overstate this. The FAQ says “we are proud to hold FDA approval”, and the US pens page says “FDA, ISO13485, and CE marking approved”. A 510(k) is a clearance, not an approval (how the two differ). The FAQ also says microneedling is “safe for all skin types and colors”, while the clearance excludes Fitzpatrick type VI.
Outside the US. In November 2019 Professional Beauty reported that the Dermapen 4’s entry on Australia’s register of therapeutic goods (the ARTG) had been cancelled for “the failure of the sponsor … to provide information to the Secretary about the safety and efficacy of the product”. The company called it a temporary classification dispute. Its current ARTG status is unverified: the TGA’s search did not respond to our check. DermapenWorld says its devices carry a CE Declaration of Conformity, which is also unverified.
What the evidence shows
The best evidence for this exact pen is the sponsor’s own clinical data, summarised in the 510(k). It has not been published in a journal as far as a PubMed search shows (zero results for “dermapen 4”).
- Study 1: single center, 22 adults with acne scars, two sessions four weeks apart (four patients had a third). Blinded evaluators found a 1-point improvement on the Acne Scar Assessment Scale in 17 of 22 (77%) four weeks after the second session, and “No patient’s acne scarring worsened.”
- Study 2: two centers, 20 adults, three sessions. Two blinded physicians rated 14 of 20 and 17 of 20 as improved by at least one grade. Post-treatment redness was graded severe in 9 of the 20, and one patient had “excessive swelling” that resolved within 96 hours.
Both studies applied a numbing cream before treatment, and in Study 2 the mean patient pain score was 5.7 on a 0–10 scale. DermapenWorld’s FAQ says “There’s no need for numbing creams with both our home Dermapen HOME and our professional devices.” The company’s own clearance data does not support that sentence.
Independent studies use the word “dermapen” but do not, in their abstracts, say which device they used. A 2024 split-face trial in 10 patients found no significant difference between a dermaroller and a “dermapen” for atrophic acne scars, and a 2019 randomised study of 60 patients found dermapen microneedling plus Jessner’s peel beat either one alone (both in Sources). The abstracts don’t name DermapenWorld or the Dermapen 4, so they are not evidence for this model in particular.
What practitioners and patients say
There is no public pool of owner reviews to read, because the pen is not sold to the public. Praise on DermapenWorld’s pages comes from clinic testimonials the company chose, such as “Dermapen 4 just delivers”, which is not independent evidence. The most relevant public discussion is a practitioner deciding between the two best-known cleared pens:
It is titled “Dermapen vs. SkinPen – Which is Better for My Practice?” and the snippet asks for input from people who have used either.
An FDA MAUDE search on October 6, 2026 found two adverse-event reports with “Dermapen” as the brand. One lists the manufacturer as unknown and the other as “Derma Pen, LLC”, and neither names a model, so they can’t be tied to the Dermapen 4. No report naming the DP4 or Equipmed USA turned up.
Service, warranty and privacy
DermapenWorld’s US provider page lists a “7-YEAR WARRANTY”, and the Dermapen 4 page describes “a fully transferable warranty, including parts and labour”. The company’s general FAQ also gives “For the first 24 months of ownership”, but that answer sits under its Dermapen HOME and LED headings, so it reads as the warranty for those home devices rather than the professional pen. The full terms for the professional pen are not public. The Dermapen 4 page also says syncing the pen “is critical to ensure the registration and warranty of the device”.
The published return policy covers the Dermapen HOME, LED masks and skincare only. For faulty products the policy says “We do not provide a refund for faulty products”; the company replaces them instead. DermapenWorld’s Trustpilot page refused our automated request (HTTP 403), so its complaint record is unverified here.
On privacy, the FDA summary says the companion app “contains no patient data and transmits no patient data.” The US privacy notice is a general template and contradicts itself on cards: one paragraph says card information “is never taken by us”, and a later one is headed “We retain your credit card information securely”.
Cartridges and running cost
Each patient session uses one sterile cartridge, and the RFID tag stops it being used again once removed. Each session also uses one single-use sleeve. The cleared treatment protocol is “3 treatments spaced 4 weeks apart”, so for a clinic:
- consumables per patient course = 3 × (cartridge price + sleeve price)
DermapenWorld publishes neither price, nor the price of the pen. A figure of $699–5,995 circulates for the device; it is unverified and does not come from the manufacturer. Reddit is no more precise:
In that thread’s snippet a reply says “dermapen is almost 500 euro”, naming no model. For a patient, the real cost is the clinic’s price per session times the number of sessions, and clinic prices vary.
How it scored
- Safety (8): FDA-cleared for this exact model with sterile single-use cartridges, RFID reuse lock and a sterile barrier sleeve, losing points for safety wording that overstates the clearance (“FDA approval”, “safe for all skin types”) and an Australian register cancellation whose resolution is unverified.
- Build (8): The 510(k) documents the needle spec, the motor-and-cam drive, IEC 60601 electrical testing and a measured depth tolerance of +0.05/−0.4 mm, and we found no documented failure modes, though there’s no independent teardown.
- Performance (8): A 0.2–3 mm range, adjustable 80–110 Hz frequency, corded or cordless power and a digital depth display; the operating instructions sit behind the provider portal, so they could not be assessed.
- Value (5): The device, cartridge and sleeve prices are all unpublished, so the yearly cost cannot be calculated and the category gets the neutral score.
- Service (6): A 7-year transferable warranty is long, but the company publishes no full terms for the pro pen, no returns route for it, and no complaint record we could check.
- Privacy (5): The app transmits no patient data per the FDA summary, but the privacy notice is a self-contradicting template and no incident record was found either way, so it gets the neutral score.
- Evidence (6): Specs and two clinical studies are public through the FDA, but neither study appears in a journal, and the marketing contradicts the record on “approval”, numbing cream and skin types.
Alternatives
- SkinPen Precision: the predicate device in the DP4’s own 510(k), cleared for acne scars and also a prescription pen. Its depth setting runs “0 – <2.7 mm” against the DP4’s 0.2–3 mm.
- Dermapen HOME: the same company’s home pen, adjustable from level 1 to 4, sold to the public. It is a different device, and its FDA status is covered on our FDA lookup page.
- Other professional pens: Collagen P.I.N., SkinStylus SteriLock, Rejuvapen NXT and other pens with their own clearances.
FAQ
Is the Dermapen 4 FDA approved? No. It is FDA-cleared through a 510(k), which is a different and lighter process than approval. The clearance (K221070) names the “DP4 Microneedling device” and covers prescription use for facial acne scars.
Can I buy a Dermapen 4 for home use? No. DermapenWorld sells it only to Authorised Treatment Providers, and the FDA clearance is for use by physicians and “suitably qualified personnel”. The company’s home device is the Dermapen HOME.
Dermapen 4 or SkinPen: which goes deeper? The Dermapen 4. Per the FDA comparison table, its setting runs 0.2–3 mm against the SkinPen’s 0 to under 2.7 mm, and its studies went to 2.5 mm against the SkinPen’s 1.5 mm. No published study compares the two pens head to head.
Does Dermapen 4 treatment hurt? Usually somewhat. Both cleared studies used a numbing cream first, and Study 2 recorded a mean pain score of 5.7 out of 10.
Is the Dermapen 3 discontinued? Unverified. DermapenWorld’s US pens page lists the Dermapen 4, Dermapen PRO and Dermapen HOME, and no Dermapen 3, but the company has not said it is discontinued.
Sources
- FDA 510(k) K221070, “DP4 Microneedling device”, decision letter, indications and 510(k) summary (checked 2026-10-06): https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221070.pdf
- FDA 510(k) database entry for K221070: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221070
- DermapenWorld US, Dermapen 4 page (checked 2026-10-06): https://www.dermapenworld.com/en-us/dermapen-professional/dermapen-microneedling-pens/dermapen-4
- DermapenWorld US, microneedling pens for clinics (checked 2026-10-06): https://www.dermapenworld.com/en-us/dermapen-professional/dermapen-microneedling-pens
- DermapenWorld US, become an authorised treatment provider (checked 2026-10-06): https://www.dermapenworld.com/en-us/dermapen-professional/become-authorised-treatment-provider
- DermapenWorld US, FAQs (checked 2026-10-06): https://www.dermapenworld.com/en-us/faqs
- DermapenWorld US, returns and exchanges (checked 2026-10-06): https://www.dermapenworld.com/en-us/returns-exchanges
- DermapenWorld US, privacy policy (checked 2026-10-06): https://www.dermapenworld.com/en-us/privacy-policy
- Professional Beauty, “Dermapen 4 loses TGA approval – temporarily” (November 20, 2019): https://www.professionalbeauty.com.au/beauty/dermapen-4-loses-tga-approval-temporarily/
- FDA MAUDE via openFDA, brand “dermapen” (searched 2026-10-06): https://api.fda.gov/device/event.json?search=device.brand_name:dermapen
- Search result listing “Dr. Pen Dermapen Rechargeable / With Plug” (Dr. Pen M5 Gold): https://skinmaxtech.com/products/dr-pen-dermapen-rechargeable-with-plug
- eBay “Derma Pen” search listing: https://www.ebay.com/shop/derma-pen?_nkw=derma+pen
- PMID 39591948: Atrophic facial acne scars; bilateral comparison of two microneedle devices. J Cosmet Laser Ther, 2024.
- PMID 31495242: Microneedling (Dermapen) and Jessner’s solution peeling in treatment of atrophic acne scars: a comparative randomized clinical study. J Cosmet Laser Ther, 2019.
- Health Canada Medical Devices Active Licence Listing, device-name search “Dermapen” (checked 2026-10-06): https://health-products.canada.ca/api/medical-devices/device/?device_name=DERMAPEN&lang=en&type=json