SkinPen Precision Review

SkinPen is the microneedling pen with the deepest regulatory record in the US, and it is a clinic device, not a home one. The FDA granted the SkinPen Precision System a De Novo request on March 1, 2018, which created the FDA’s device category for microneedling (21 CFR 878.4430). Two 510(k) clearances followed for the same pen, and a third in 2024 for the SkinPen Precision Elite. The cleared uses are facial acne scars in adults of all Fitzpatrick skin types and neck wrinkles in types II to IV. The pen’s manual states “Federal law restricts this device to sale by or on the order of a physician”, so getting SkinPen microneedling means booking a provider. Results in the trials behind the clearance were real but modest: blinded dermatologists graded 11 of 20 acne-scar patients as improved at six months, and 9 of 20 as unchanged. This review is based on documented evidence; nobody at this site has used the device.

Who it suits, and who it doesn’t

For: practices that want the pen with the most published regulatory data behind it, and patients who want to know what their clinic is using. Its acne-scar clearance is one of the few that names all skin types, which matters if you have darker skin (more on that below).

Not for: anyone shopping for a pen to use at home. It is not sold to the public, and the clearance describes the target user as “Healthcare professionals trained in use of the device” in a “Clinical” environment. This is the most common question about it online:

Is the SkinPen microneedling good to use at home?
byu/EMAILZENHP-4469 inReview

That thread is titled “Is the SkinPen microneedling good to use at home?” Any “SkinPen” offered to consumers did not come through Crown Aesthetics’ channel, which sells to practices. For a home device, see the alternatives below.

Specs

Figures come from the FDA documents and the SkinPen Precision user manual (Crown Aesthetics, 2021) unless marked.

	SkinPen Precision / Precision Elite
Needles	“14 total solid medical grade stainless steel”, “32 BWG (gauge)” (manual)
Depth range	“11 depth settings from 0 mm to 2.5 mm in 0.25 mm increments” (De Novo summary)
Depth tolerance (bench test)	Within “+0 mm/-0.25 mm of the selected needle depth” at every setting
Speed	One speed: “7000 RPMs (6300-7700 RPMs)”; “105-128.3 Hz”
Puncture rate	“1470-1797 punctures/sec” (K241400 comparison table)
Power	Cordless, rechargeable lithium-ion, inductive charging base; “Working Time > 6 hours” (manual)
Weight	“5oz”, 155 mm long (manual)
Cartridge	Sterile (ethylene oxide), single use, with a lockout that stops a used cartridge being refitted; the Elite adds an NFC chip
Cartridge shelf life	“2 years from sterilization date” (manual)
Barrier	“BioSheath”, a “nonsterile, disposable cover” over the handpiece
Tested use life	“at least 2000 hours” of handpiece use (De Novo bench test)
Warranty	Precision: “One year under normal use”; Elite: “Lifetime Warranty”, terms not published (see Service)
Price	Not published

Depth is set by turning the cartridge head, not on the pen. The bench test is the reassuring number here: across all 11 settings the needles never went deeper than the dial, and fell short by at most 0.25 mm.

Speed is fixed. Unlike pens with an adjustable frequency, SkinPen runs at one motor speed, so the operator controls the treatment through depth and passes only.

Precision vs Precision Elite: what changed

Very little that touches the skin. The Elite’s 510(k) (K241400, cleared August 29, 2024) lists the same needle count, the same 2.5 mm maximum, the same frequency and the same indication as the SkinPen Precision. The two differences the FDA table records are an “LCD screen” that shows “whether the cartridge is correctly installed” and cartridge authentication by “NFC Chip” in place of the “Manual lock out”. The summary also mentions changed “cartridge connection points”, and says “No Clinical testing was conducted as part of this submission”. The Elite therefore rests on the original pen’s clinical data.

Crown’s December 2024 launch release adds what the FDA file doesn’t: a new cartridge “minimizing risk for accidental lockouts”, “active retraction technology powered by the all-new ActiSine™ technology”, an “Elite Efficiency Timer”, and a “Lifetime Warranty”. The line about accidental lockouts suggests the original cartridge could lock itself out during installation. That is the company’s own framing; we found no independent report of it.

FDA status: what each record covers

All four records are prescription-only and sit under 21 CFR 878.4430, “Microneedling device for aesthetic use”, a regulation that exists because of SkinPen.

Record	Date	Applicant	What it did
DEN160029	2018-03-01	Bellus Medical, LLC	De Novo grant for facial acne scars, adults 22+; created the device category
K202243	2021-04-02	Crown Aesthetics	Added neck wrinkles, backed by a new clinical study
K220506	2022-03-07	Crown Aesthetics	Same indication; a new disinfecting cloth (Sani-Cloth AF3)
K241400	2024-08-29	Crown Aesthetics	SkinPen Precision Elite

The current indication, identical in K202243, K220506 and K241400, quoted from the record:

“The SkinPen® Precision system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II – IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older.”

The skin-type wording is the unusual part. The Dermapen 4’s clearance, for comparison, stops at type V. SkinPen’s acne-scar study enrolled patients of types II to VI (“11/41 subjects with Fitzpatrick Skin Type (FST) V and VI”), and the FDA’s reviewers wrote that “The higher Fitzpatrick Skin Types were studied appropriately”. Type I was not studied; the FDA accepted that because lighter skin is not at higher risk of pigment problems. The neck clearance is narrower: types II to IV only.

Three other limits sit in the record. The device “is restricted to prescription use”. It is “not intended for transdermal (under the skin) delivery of topical products”. And for acne scars the De Novo summary says “Safety and effectiveness for needle depth settings greater than 1.5 mm has not been evaluated.” The pen dials to 2.5 mm. The 2.5 mm setting was later studied on the neck, not the face. The 2021 manual is inconsistent on this: one step says “a maximum depth of 2.5mm on the face and neck areas”, the next says “a maximum depth of 1.5 mm on the face and 2.5 mm on the neck areas”.

“FDA approved” is wrong for this pen, and the phrase is everywhere, including a thread title in our research:

[review] skinpen with exoxomes
byu/Diverscientist inSkincareAddiction

Its snippet reads “FDA has approved skinpen”. Crown’s own product page says SkinPen “is approved for use on the face and an area of the body”. A De Novo grant and a 510(k) clearance are both different from an approval (how they differ).

Outside the US. Health Canada’s medical device licence database lists licence 99476, “SKINPEN MICRONEEDLING SYSTEM WITH SKINPEN + SKINFUSE TREATMENT KIT”, Class II, first issued August 1, 2017, and licence 113914 for the “SKINPEN PRECISION ELITE MICRONEEDLING SYSTEM”, first issued September 3, 2025, both in the active list as of October 5, 2026. The Canadian indication is not given in that listing and is unverified. The 2021 manual says the device “is classified as Class IIa per MDD 93/42/EEC”, the EU directive since replaced by the MDR; its current CE status is unverified.

SkinPen before and after: what the trials showed

The best evidence is the sponsor’s own, and it is more public than most pens get: the FDA posted the full acne-scar trial, and the neck trial appears both in the 510(k) and in a journal.

Acne scars (the De Novo trial). Single center, three treatments a month apart, by “a trained aesthetician”, with the face numbed first and depth capped at 1.5 mm. Of the 41 people who finished, “Only 20 of these subjects were treated with the SkinPen Precision System”; the other 21 used a prototype, so the effectiveness figures come from 20 people. Two blinded dermatologists graded photos on a 0 to 4 scar scale:

• the mean score went from 2.80 at baseline to 2.35 at six months;
• 7 of 20 improved by a full grade, 4 more improved by less than a grade, and “the remaining 9 subjects (45%) reported no change”;
• nobody was graded worse at six months.

Patients rated themselves more generously: 18 of 20 reported some improvement, with a mean score in the “1%-25% improvement” band.

Thirteen of the 33 people enrolled in the SkinPen group dropped out, 12 of them before any treatment, including five the sponsor removed “for not having severe acne scars based on the images reviewed.”

On safety, the summary reports “no serious AEs or reports of nerve and tissue damage”. Across all 41 subjects, short-lived responses included redness, itching, peeling, discomfort and tenderness in 31% for 1 to 3 days, dryness in 12% and burning in 9%. One subject developed skin striae, judged “possibly related” and attributed to sun exposure against instructions; it resolved.

Neck wrinkles (K202243). 35 enrolled, 32 completed, aged 44 to 65, almost all women, three-quarters type II. Four monthly treatments at up to 2.5 mm, under physician supervision. On a wrinkle scale, 16 of 32 (50%) improved by a grade at three months. The blinded clinicians’ global rating was less positive: “57% received a grading of ‘4: no change'”. The study was published in Aesthetic Surgery Journal in 2022 by authors including Crown Laboratories employees. Its abstract reports satisfaction of 93.8%, 87.5% and 80.6%; in the 510(k) tables those are the one-month figures, and by three months they had fallen to 71.9% noticing improvement and 65.6% willing to recommend it.

A companion paper from the same sponsor reports facial wrinkle results from what looks like the same cohort (35 enrolled, 32 completed, mean age 56.3). Neither abstract names SkinPen. Both describe an FDA-cleared pen indicated for acne scars, and both list Crown Laboratories as an author affiliation. A PubMed search for “skinpen” returns one unrelated paper, a wound-care bioprinter that shares the name, and we found no independent trial of this pen.

Crown’s site has a before-and-after gallery. Its images load by script and carry no case details we could read, so we can’t say what settings or how many sessions they show.

One detour on acne. A Cosmopolitan review that ranks for this search says SkinPen “can actually be used on active breakouts”. The manual says “Avoid treatment on patients with active breakouts or open lesions” and lists active acne among conditions the system “has not be[en] evaluated” in. Crown Laboratories employees have since published a pilot study of microneedling for active acne, but its abstract does not name the device.

Adverse event reports

An openFDA search of the FDA’s MAUDE database on October 6, 2026 found 13 reports with “SkinPen” in the brand name, the earliest received in 2022 and the latest in July 2026. All 13 are coded as injuries. Two name the Precision Elite. Recorded patient problems include skin infection (four reports), allergic reactions including one coded “Anaphylactoid / Anaphylaxis”, scarring and hyperpigmentation, and five reports are tagged “Off-Label Use”.

MAUDE reports are unverified submissions. A report does not show the device caused the problem, and counts can’t be turned into a rate because nobody knows how many treatments were done.

Service, warranty and privacy

The 2021 SkinPen Precision manual gives “One year under normal use after its original purchase”, for the original purchaser only, excluding misuse and unauthorised repair. The Elite launch release promises a “Lifetime Warranty”, footnoted “Terms and Conditions Apply”; we could not find those terms, so what “lifetime” covers is unverified.

Crown Aesthetics has a BBB listing with an A+ rating (it is not accredited). We did not read a complaint history there, and Trustpilot refused our request (HTTP 403), so the complaint record is unverified. The consumer site, skinpen.com, returned a “Vercel Security Checkpoint” block to every request we made, so nothing on it is used here.

On privacy, Crown’s pages link to Revance’s privacy policy and a separate “Health Data Privacy Policy” (Crown is “A Revance Company”). Both returned HTTP 429 to our requests, so neither was read.

Cartridges and running cost

Every treatment uses one sterile cartridge and one BioSheath, sold together in a treatment kit. Using the site’s standard schedule (one full-face session every four weeks, 13 a year):

• yearly cost for one patient = 13 × (treatment kit price)
• first-year cost for a practice = device price + kits used

Crown publishes neither the device price nor the kit price, so neither line can be filled in. A clinic-supply blog, Portrait, says “One owner paid about $7,500 with 18 treatment kits”; that is a single secondhand anecdote, unverified, and it doesn’t separate the pen from the kits.

For a patient, the number that matters is the clinic’s price per session. Portrait puts most single sessions at “$250 to $700”, also unverified. One Reddit poster’s figure:

Microneedling experience- Skin pen Vs + PRP Vs + injectable (not botox)
byu/Theshortcarlson inSkincare_Addiction

In that thread’s snippet the poster is “considering micro needling with skin pen ($900 for 3 sessions)”. The cleared protocols used three sessions for acne scars and four for the neck.

How it scored

• Safety (9): FDA-authorised for this exact pen and the Elite, with an acne-scar indication tested across skin types II to VI, EO-sterile single-use cartridges with a reuse lockout, and validated fluid-ingress protection; it loses a point for “approved” wording and a manual that gives both 1.5 mm and 2.5 mm as the face maximum.
• Build (8): The De Novo bench tests document depth accuracy (+0/−0.25 mm), a 2,000-hour use life, needle pull strength and suction prevention, but there is no independent teardown and the Elite release implies the older cartridge could lock out by accident.
• Performance (7): A 0 to 2.5 mm range in 0.25 mm steps, cordless with over six hours’ use and an LCD on the Elite, but one fixed speed and a shallower range than the Dermapen 4.
• Value (5): The device and treatment-kit prices are unpublished and the only price is a single unverified anecdote, so the yearly cost can’t be calculated and the category gets the neutral score.
• Service (6): A published one-year warranty on the Precision and a “lifetime” warranty on the Elite whose terms we couldn’t find, with no complaint record we could read.
• Privacy (5): Both privacy policies blocked our requests and we found no incident record either way, so it gets the neutral score.
• Evidence (7): The full pivotal trial is public through the FDA and the neck trial is in a peer-reviewed journal, which is more than most pens have; it loses points because every study is sponsor-run, the acne trial had 20 device patients, and the marketing says “approved”, while SkinPen’s international provider page calls the 2024 Elite “the first FDA-cleared microneedling device”.

Alternatives

• Dermapen 4: the other well-known clinic pen. FDA-cleared (as the “DP4”) for acne scars in types I to V, with SkinPen Precision as its predicate. It dials to 3 mm and has an adjustable frequency; its studies have not been published in a journal.
• Dr. Pen A20: the only Dr. Pen model with a 510(k) (K230420), also for prescription use. See its review for the Health Canada advisory that names the Dr. Pen brand.
• Other professional pens: Rejuvapen NXT, SkinStylus SteriLock, Collagen P.I.N. and Eclipse Medcorp’s MicroPen EVO, each with its own clearance.

FAQ

Is SkinPen FDA approved? No. It was authorised through a De Novo grant (DEN160029) in 2018 and has since been cleared through three 510(k)s. Neither route is an approval. All four records are for prescription use.

Can I buy a SkinPen for home use? No. The manual says federal law restricts sale to “by or on the order of a physician”, and the clearance names trained healthcare professionals in a clinic as the users.

What is the difference between SkinPen Precision and Precision Elite? A screen and the cartridge. The Elite’s 510(k) records an LCD screen and NFC cartridge authentication, with the same needles, depth, speed and indication, and no new clinical testing.

How many SkinPen sessions does it take? Three in the acne-scar trial and four in the neck trial, a month apart. In the acne trial, 9 of 20 patients showed no change on the blinded scar grade after three sessions and six months.

Does SkinPen work on dark skin? Its acne-scar clearance covers all Fitzpatrick types, and 11 of the 41 trial subjects were type V or VI. The manual warns that “in Fitzpatrick IV–VI, pigment may darken prior to lightening.” The neck clearance covers types II to IV only.

Sources

• FDA De Novo DEN160029, classification order, SkinPen Precision System (checked 2026-10-06): https://www.accessdata.fda.gov/cdrh_docs/pdf16/DEN160029.pdf
• FDA De Novo decision summary for DEN160029 (clinical study, bench testing, labeling) (checked 2026-10-06): https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN160029.pdf
• FDA 510(k) K202243, SkinPen Precision System, neck wrinkles (checked 2026-10-06): https://www.accessdata.fda.gov/cdrh_docs/pdf20/K202243.pdf
• FDA 510(k) K220506, SkinPen Precision System (checked 2026-10-06): https://www.accessdata.fda.gov/cdrh_docs/pdf22/K220506.pdf
• FDA 510(k) K241400, SkinPen Precision Elite System (checked 2026-10-06): https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241400.pdf
• SkinPen Precision user manual / instructions for use, Crown Aesthetics, PN P5SP064.00 (checked 2026-10-06): https://crownaesthetics.com/wp-content/uploads/2021/04/SkinPen-IFU-User-Manual.pdf
• SkinPen Precision Elite System patient labeling (checked 2026-10-06): https://elite.skinpen.com/wp-content/uploads/2024/11/P5SP223.00_SP_Elite_System_Patient_Labeling_11x13.5_20240905_lowres.pdf
• Crown Aesthetics, SkinPen product page (checked 2026-10-06): https://crownaesthetics.com/products/skinpen-elevating-the-highest-standard-in-microneedling/
• Crown Aesthetics, SkinPen before and after (checked 2026-10-06): https://crownaesthetics.com/before-and-after/
• Crown Laboratories, “Crown Aesthetics Announces U.S. Launch of the SkinPen® Precision Elite” (December 10, 2024): https://crownlaboratories.com/news/crown-aesthetics-announces-u-s-launch-of-the-skinpen-precision-elite-the-new-standard-in-microneedling/
• SkinPen International, SkinPen Precision Elite for providers (checked 2026-10-06): https://skinpeninternational.com/for-providers/skinpen-precision-elite/
• Health Canada Medical Devices Active Licence Listing, licences 99476 and 113914 (checked 2026-10-06): https://health-products.canada.ca/api/medical-devices/licence/?id=99476&lang=en&type=json
• FDA MAUDE via openFDA, brand “skinpen” (searched 2026-10-06): https://api.fda.gov/device/event.json?search=device.brand_name:skinpen
• Portrait, “SkinPen Cost for Clinics: Device and Supply Prices 2026” (October 2, 2026): https://www.portraitcare.com/post/skinpen-cost-guide-full-clinic-cost-breakdown-2026
• Cosmopolitan, SkinPen review (search snippet, May 14, 2026): https://www.cosmopolitan.com/style-beauty/beauty/a71244200/skinpen-review/
• BBB search listing, Crown Aesthetics (checked 2026-10-06): https://www.bbb.org/search?find_text=crown%20aesthetics
• PMID 35397167: Efficacy and Tolerability of a Microneedling Device for Treating Wrinkles on the Neck. Aesthet Surg J, 2022.
• PMID 35403786: Efficacy and tolerability of a microneedling device for treating wrinkles on the face. J Cosmet Dermatol, 2023.
• PMID 37799356: Study to determine the safety and efficacy of microneedling as an effective treatment for acne vulgaris. Skin Health Dis, 2023.
• PMID 37262337: Portable Handheld “SkinPen” Loaded with Biomaterial Ink for In Situ Wound Healing. ACS Appl Mater Interfaces, 2023.