Professional Microneedling Pens: Every FDA-Cleared Device Compared

A “professional” microneedling pen, in the FDA’s sense, is one cleared under product code QAI, and every one of them is a prescription device cleared for a named job. On October 6, 2026 the FDA’s 510(k) database held 26 records under that code. Twenty-three cover 14 pens; the other three cover skin-coring machines, which are a different technology. All 26 are marked for prescription use, none for home or over-the-counter use. And no pen is cleared for “microneedling” in general: each record names a condition (usually facial acne scars, sometimes wrinkles in named areas or scars on the abdomen), a minimum age of 22 (34 for one indication), and often a narrower range of Fitzpatrick skin types. The table below lists all of them. Three have full reviews on this site; the rest are described from their FDA summaries and are not scored or ranked.

Every cleared pen at a glance

Each FDA number links to the 510(k) or De Novo summary it comes from. “Cleared depth” is the depth range the summary gives for the device being cleared (the subject device), not the predicate it was compared against; where the summary also limits the depth that was studied or recommended, that is noted.

Device Applicant FDA records Cleared for Skin types (Fitzpatrick) Cleared depth Needles
SkinPen Precision / Elite (6.9/10) Bellus Medical; Crown Aesthetics DEN160029, K202243, K220506, K241400 Facial acne scars; neck wrinkles Acne scars: all. Neck: II–IV 0–2.5 mm; acne scars not evaluated above 1.5 mm 14, 32 gauge
Dermapen 4 (as “DP4”) (6.8/10) Equipmed USA K221070 Facial acne scars I–V 0.2–3 mm 16, 33 gauge
Dr. Pen A20 (5.6/10) Guangzhou Ekai Electronic Technology K230420 Facial acne scars None stated 0–2.0 mm 14, 34 gauge
Exceed / Exceed Unlimited Mt. Derm GmbH K180778, K182407, K233709 Wrinkles (frown lines, eye lines, cheek folds); facial acne scars Wrinkles: I–III. Acne scars: I–IV Dial 0–1.9 mm; needles 1.5 mm long, so 1.5 mm maximum 6
Rejuvapen NXT Refine USA K192138 Periorbital wrinkles only I–IV 0–2.5 mm; not recommended above 1.3 mm 12 (32 gauge in the trial)
SkinStylus SteriLock Esthetic Education; Esthetic Medical K200044, K231073, K253002 Abdominal surgical or traumatic hypertrophic scars; facial acne scars; periorbital wrinkles Abdomen: none stated. Acne scars: I–III. Eye wrinkles: I–VI (age 34+) 0–2.5 mm 12 or 36, 32 gauge
MicroPen EVO Eclipse Medcorp K203144, K212558 Facial acne scars; neck wrinkles Acne scars: all (K212558). Neck: II–IV 0–2.0 mm; 1.5 mm recommended 14, 32 gauge
Collagen P.I.N. Induction Therapies K222199 Facial acne scars I–III 0–3.0 mm 36, 35 gauge
SER Pen Carain Su-Ko Technologies K241355, K253153 Facial acne scars; abdominal hypertrophic scars Acne scars: I–III. Abdomen: none stated 0–2.5 mm 12 or 36 (gauge not stated)
XCellarisPRO TWIST Dermaroller GmbH K241790 Facial acne scars; wrinkles (frown lines, eye lines, cheek folds) Acne scars: I–IV. Wrinkles: I–III 0–2.5 mm; 1.5 mm recommended maximum 6
1NEED Pro Campomats S.R.L. K243472 Facial acne scars None stated 0–2.0 mm; 1.5 mm recommended 14, 34 gauge
E-PEN Bomtech Electronics K243143 Facial acne scars None stated 2.0 mm maximum setting; not evaluated above 1.5 mm 14, 34 gauge
Dermalogica PRO Pen (6883) Dermalogica K243800 Facial acne scars None stated Up to 1.5 mm in 0.2 mm steps 14 (same gauge as the Dr. Pen A20)
CODE-X Woorhi Mechatronics K252591 Facial acne scars None stated 0–2.0 mm in 0.2 mm steps; 1.5 mm recommended 12 or 14, 33 gauge

Every indication also sets a minimum age of 22, apart from SkinStylus’s eye-wrinkle clearance, which starts at 34. “None stated” means the indication names no skin types. It does not say the device was tested on all of them, and the summaries for those pens report no clinical study that would show it either way.

What the table says that the brochures don’t

Most of these pens are cleared for one thing: facial acne scars. Wrinkle clearances are rarer and tightly drawn. The Rejuvapen NXT is cleared for wrinkles around the eyes and nothing else. Exceed and XCellarisPRO TWIST cover three named areas: glabellar frown lines, periorbital lines and cheek folds. SkinPen and MicroPen EVO cover the neck. No record in the table mentions hair loss, stretch marks, pigmentation or general “skin rejuvenation”.

The dial goes deeper than the evidence. Rejuvapen NXT dials to 2.5 mm, but its summary says “It is not recommended to use the device at depths greater than 1.3mm”, and its trial capped treatment at 1.3 mm. SkinPen’s De Novo summary says safety and effectiveness on acne scars above 1.5 mm “has not been evaluated”, and the E-PEN summary repeats that wording. XCellarisPRO TWIST reaches 2.5 mm with “a recommended maximum needle penetration depth of 1.5 mm”. The exception is Collagen P.I.N.: in its acne-scar trial the deepest setting used per patient ranged from 1.0 to 3.0 mm, with means of 2.06 to 2.36 mm.

Skin type limits track who was in the trial. Collagen P.I.N. is cleared for types I–III only. Its summary reports that six of the 25 acne-scar patients had a treatment-related side effect, all of it “post-inflammatory pigment change”, and “all 6 subjects who experienced TRAEs had Fitzpatrick skin type IV to VI.” The Exceed acne-scar study (K182407) enrolled no type V or VI patients, and that clearance stops at type IV. At the other end, SkinStylus’s 2026 eye-wrinkle clearance covers types I–VI after a trial that included four type V and four type VI patients out of 51.

Several clearances rest on bench tests alone. The summaries for the Dr. Pen A20, SER Pen Carain, XCellarisPRO TWIST and CODE-X state or show that no clinical study was done; the 1NEED Pro and E-PEN summaries describe bench testing only. Three of these (the 1NEED Pro, Dermalogica PRO Pen and CODE-X) name the Dr. Pen A20 as their predicate, and the A20 was itself cleared on bench data against the SkinPen. A 510(k) asks whether a device is “substantially equivalent” to one already on the market, so this is how the system is designed to work, but it means the clinical evidence for those pens is the SkinPen’s.

Questions to ask a clinic before a treatment

  1. Which device, exactly? The brand and the model. “A medical-grade pen” is not an answer.
  2. What is its FDA number? Any number in the table above can be checked against the FDA database, and our FDA lookup table links each one.
  3. Is my treatment inside the cleared indication? Compare the area (face, eyes, neck, abdomen), the condition (acne scars or wrinkles) and your skin type with the row in the table. Rejuvapen NXT on acne scars, or Collagen P.I.N. on type V skin, is outside what the FDA reviewed for that pen.
  4. How deep will you go, and was this device studied at that depth? The answer should sit inside the cleared or recommended range in the summary.
  5. Is the cartridge new, sealed and single use? Every summary here describes a sterile single-use cartridge.

A clearance tells you the FDA reviewed the device for the use it names. It says nothing about a use it doesn’t name. For what clearance does and doesn’t mean, see microneedling and FDA clearance.

One misunderstanding comes up repeatedly in clinic forums:

Price and reviews
byu/Similar_Cow5343 inEsthetics

The snippet of that r/Esthetics thread, titled “Price and reviews”, reads “The skin pen I last heard was the only FDA approved microneedling device.” Neither half holds: SkinPen was the first (its 2018 De Novo grant created the category), not the only one, and none of these devices is “approved”, which is a different FDA process from clearance.

The pens, one by one

SkinPen, Dermapen 4 and Dr. Pen A20

These three have full reviews. SkinPen (6.9/10) is the reference device most others were compared against, with the broadest acne-scar skin-type wording and a public pivotal trial. Dermapen 4 (6.8/10) is cleared under the name “DP4”, for acne scars in types I–V, and dials to 3 mm. Dr. Pen A20 (5.6/10) is the only Dr. Pen model with a 510(k), cleared to 2.0 mm on bench data, and sold to consumers despite its prescription clearance.

Exceed and Exceed Unlimited (Mt. Derm)

The Exceed was the second pen cleared after SkinPen, in September 2018 (K180778). It uses a six-needle square plate whose needles are only 1.5 mm long, so although the dial reads to 1.9 mm, 1.5 mm is as deep as it goes. The first Exceed has a separate control unit powered by a wall transformer, with the frequency set between 100 and 150 Hz.

Its wrinkle indication is narrow for a reason the summary spells out. Blinded assessors graded six facial areas in a 48-person trial; “three areas achieved a clinically meaningful result, while three areas did not show improvement.” The clearance names the three that did: glabellar frown lines, periorbital lines and cheek folds. Forehead lines, nasolabial folds and upper lip lines did not improve meaningfully and are not in the indication.

The acne-scar clearance (K182407) followed in 2019. In that study, “A 1 grade improvement was seen in 27/46 (59%) of subjects” and 8 of 46 showed no improvement. Exceed Unlimited (K233709, February 2024) carries both indications and moves the power to a battery in the handpiece; the summary lists the same needles, protrusion range and frequency as the original.

Rejuvapen NXT (Refine USA)

Rejuvapen NXT, cleared in April 2020 (K192138), is the only pen cleared solely for periorbital wrinkles, in skin types I–IV. It plugs into the wall, has 12 needles in two circles (8 outer, 4 inner) and nine speed steps from 80 to 110 Hz. The dial reaches 2.5 mm; the summary does not recommend going past 1.3 mm.

The trial recruited 52 adults and 46 finished four treatments, four weeks apart, at up to 1.3 mm. “Nineteen out of 45 subjects, 42% had at least a one grade improvement according to both assessors.” Redness was the main short-term effect: 26% of patients rated it severe immediately after treatment, and 96% rated it mild, minor or absent by the evening of day three.

A naming note: the top Google result for “rejuvapen”, a plastic surgery practice’s page, describes “Nine micro-needles” (per its search snippet). The NXT’s 510(k) says 12. The practice may be describing an earlier Rejuvapen; any pen without “NXT” in the name has no FDA record of its own under QAI.

SkinStylus SteriLock

SkinStylus has three clearances and the widest spread of indications. The first (K200044, April 2020) was for surgical or traumatic hypertrophic scars on the abdomen, a use no other pen covered until the SER Pen Carain. K231073 (2023) added facial acne scars in types I–III. K253002 (February 2026) added periorbital wrinkles in types I to VI, adults 34 and over. Only two other indications in this table cover every skin type, both for acne scars (SkinPen and MicroPen EVO).

That eye-wrinkle trial ran at two sites, and the result was split. The summary says the primary endpoint “was achieved for periorbital lines at site #1” and “was not achieved for periorbital wrinkles at site #2”. On blinded photo review, 80% of patients were rated improved around the eyes at day 150. The pen runs on battery or mains and takes 12- or 36-needle cartridges; its nose cone is autoclaved or disinfected between patients.

MicroPen EVO (Eclipse)

The MicroPen EVO’s two clearances (K203144 in May 2021, K212558 in November 2021) give it exactly the SkinPen’s current indication: acne scars in all skin types and neck wrinkles in types II–IV. It has the same 14-needle, 32-gauge layout as SkinPen and a shallower range, nine settings from 0 to 2.0 mm. The K212558 summary is inconsistent on the maximum: one table row says “2.25 mm”, while the same table and its text give 2.0 mm. Neither summary describes a clinical study; Eclipse ran bench tests side by side with the SkinPen.

Collagen P.I.N. (Induction Therapies)

Collagen P.I.N. (K222199, October 2022) shares the deepest cleared range here with the DP4: 0 to 3.0 mm, in 0.1 mm steps, with 36 needles of 35 gauge, the finest listed. It runs only on its battery; the summary says it is “not used while the device is plugged into the wall charging station.”

Its trial is the reason for the narrow skin-type range covered above. Of 23 acne-scar patients analysed, the investigator rated 100% as improved, while two independent graders rated 47.8% and 60.9% as improved.

SER Pen Carain (Su-Ko Technologies)

The SER Pen Carain (K241355, October 2024) carries the same two indications as SkinStylus: facial acne scars in types I–III and abdominal hypertrophic scars. Its model number, MP1209SP, differs by one letter from SkinStylus’s MP1209SL. The sponsor chose to “rely on the same performance data submitted in” the Collagen P.I.N. and SkinStylus files “and not include any clinical data”. K253153 (October 2025) added a corded seven-speed head (6,200 to 9,000 RPM) and a shortened cartridge, with no change to the indication.

XCellarisPRO TWIST (Dermaroller GmbH)

Dermaroller GmbH’s device under this product code is a pen, not a roller. Cleared in March 2025 (K241790), it combines the Exceed’s two indications and skin-type limits. Like the Exceed it uses six needles in a square, but they are 2.5 mm long, driven from a mains control unit with an optional foot switch. “No clinical studies were performed to test the XCELLARISPRO TWIST microneedling device.”

1NEED Pro, E-PEN, Dermalogica PRO Pen and CODE-X

Four recent acne-scar clearances, all 14-needle pens (CODE-X also takes 12-needle cartridges), none naming skin types:

  • 1NEED Pro (Campomats, Italy, K243472, March 2025): 34 gauge, 0–2.0 mm, predicate the Dr. Pen A20. The summary lists bench tests and a protocol of three treatments four weeks apart.
  • E-PEN (Bomtech, South Korea, K243143, April 2025): 34 gauge, predicate the SkinPen. Its comparison table gives a 2.0 mm maximum setting, but a paragraph two sentences later says the E-PEN “allows for incremental increase in settings of up to 2.5mm”. The 2.0 mm figure is in the E-PEN’s own column of the table; the 2.5 mm one is the SkinPen’s range.
  • Dermalogica PRO Pen (K243800, August 2025): the shallowest pen in the table, 1.5 mm maximum in 0.2 mm steps. Apart from mains power, the shallower depth and a three-year cartridge shelf life, the summary calls it identical to its predicate, the Dr. Pen A20, including needle count, gauge and puncture rate.
  • CODE-X (Woorhi Mechatronics, K252591, May 2026): 33 gauge, 0–2.0 mm in 0.2 mm steps, predicate the Dr. Pen A20. “Clinical testing was not necessary to establish substantial equivalency of the device.”

What these pens cost

None of the makers publishes a device price, and the figures in circulation are clinic anecdotes we could not verify. Running cost depends mostly on the cartridge, and providers compare it:

For providers: has anyone switched from SkinPen to another microneedling device?
byu/Emotional_Pilot8905 inEsthetics

In that thread, titled “For providers: has anyone switched from SkinPen to …”, the snippet says of the pen being discussed that cartridges are “about $20 each”. The snippet doesn’t name the pen, and the price is the poster’s, not a published one.

“Professional” pens without a clearance

The word “professional” is unregulated. Reddit threads on it tend to mean build quality rather than status:

Difference micro-pen bought online versus professional service
byu/Comprehensive_Set inMicroneedling

That thread is titled “Difference micro-pen bought online versus professional …”, and its snippet says “A professional pen is built to be used day in and day out.” None of the 26 QAI records mentions durability; they cover indications, depth and sterility.

MDPen is an example worth checking. Its homepage description reads “FDA-approved Corrective Microneedling devices”. An openFDA search of the 510(k) database for “mdpen” on October 6, 2026 returned no matches, and none of the 26 QAI records names MDPen. Its homepage gives no FDA number. A device might be made under another company’s clearance, so the accurate status is “no MDPen clearance found”, and the question to ask any seller is the same as for a clinic: which K-number?

Related: skin-coring devices under the same code

Three QAI records are not pens. Cytrellis (K202517, 2021) and its successor ellacor (K252752, 2025) remove skin rather than puncture it, cutting “full thickness micro-columns” with hollow needles; the first summary says as much as 7.9% of the skin surface in the treated area is removed. Both are cleared for moderate and severe wrinkles of the mid and lower face in types I–IV, and ellacor adds fractional skin resurfacing. Venus Concept’s AI.ME (K221011, 2022) is a robot-arm version: six hollow needles 0.74 mm in diameter, a fixed maximum depth of 3 mm, up to 10% of skin removed, cleared for “fractional skin resurfacing”. They share product code QAI with the pens, which is why they show up in searches for cleared microneedling devices.

FAQ

Is Rejuvapen FDA approved? No. The Rejuvapen NXT is FDA-cleared (K192138), a different process from approval, for periorbital wrinkles in skin types I–IV, prescription use only.

Is SkinPen the only FDA-cleared microneedling pen? No. It was the first, in 2018. By October 2026, 13 other pens had clearances under the same product code.

Which professional microneedling pen goes deepest? Collagen P.I.N. and the Dermapen 4 (DP4) both reach 3.0 mm in their cleared configuration. Most others stop at 2.0 or 2.5 mm, and several summaries recommend staying at or below 1.5 mm.

Which pens are cleared for darker skin? For acne scars, SkinPen (all types), MicroPen EVO (all types) and the Dermapen 4 (I–V). SkinStylus is cleared for eye wrinkles in types I–VI. Collagen P.I.N., SER Pen Carain and SkinStylus’s acne-scar clearance stop at type III.

Can I buy a professional pen for home use? Not one that is cleared for it. Every one of the 26 QAI records is for prescription use.

Sources

  • openFDA 510(k) database, product code QAI, 26 records (queried 2026-10-06): https://api.fda.gov/device/510k.json?search=product_code:QAI&limit=100
  • openFDA 510(k) database, search for “mdpen” (no matches, 2026-10-06): https://api.fda.gov/device/510k.json?search=device_name:mdpen+OR+applicant:mdpen
  • FDA De Novo DEN160029, SkinPen Precision System (checked 2026-10-06): https://www.accessdata.fda.gov/cdrh_docs/pdf16/DEN160029.pdf
  • FDA 510(k) K202243, SkinPen Precision System: https://www.accessdata.fda.gov/cdrh_docs/pdf20/K202243.pdf
  • FDA 510(k) K220506, SkinPen Precision System: https://www.accessdata.fda.gov/cdrh_docs/pdf22/K220506.pdf
  • FDA 510(k) K241400, SkinPen Precision Elite System: https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241400.pdf
  • FDA 510(k) K221070, DP4 Microneedling device: https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221070.pdf
  • FDA 510(k) K230420, Dr. pen Microneedling System: https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230420.pdf
  • FDA 510(k) K180778, Exceed Microneedling Device (wrinkles; clinical study): https://www.accessdata.fda.gov/cdrh_docs/pdf18/K180778.pdf
  • FDA 510(k) K182407, Exceed Microneedling device (acne scars; clinical study): https://www.accessdata.fda.gov/cdrh_docs/pdf18/K182407.pdf
  • FDA 510(k) K233709, Exceed Unlimited: https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233709.pdf
  • FDA 510(k) K192138, Rejuvapen NXT (specifications and clinical study): https://www.accessdata.fda.gov/cdrh_docs/pdf19/K192138.pdf
  • FDA 510(k) K200044, SkinStylus SteriLock MicroSystem (abdominal scars): https://www.accessdata.fda.gov/cdrh_docs/pdf20/K200044.pdf
  • FDA 510(k) K231073, SkinStylus SteriLock MicroSystem MP1209SL (acne scars): https://www.accessdata.fda.gov/cdrh_docs/pdf23/K231073.pdf
  • FDA 510(k) K253002, SkinStylus SteriLock MicroSystem MP1209SL (periorbital wrinkles; clinical study): https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253002.pdf
  • FDA 510(k) K203144, MicroPen EVO: https://www.accessdata.fda.gov/cdrh_docs/pdf20/K203144.pdf
  • FDA 510(k) K212558, MicroPen EVO (neck wrinkles and acne scars): https://www.accessdata.fda.gov/cdrh_docs/pdf21/K212558.pdf
  • FDA 510(k) K222199, Collagen P.I.N. (specifications and clinical study): https://www.accessdata.fda.gov/cdrh_docs/pdf22/K222199.pdf
  • FDA 510(k) K241355, SER Pen Carain MicroSystem: https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241355.pdf
  • FDA 510(k) K253153, SER Pen Carain MicroSystem (modified device): https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253153.pdf
  • FDA 510(k) K241790, XCELLARISPRO TWIST microneedling device: https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241790.pdf
  • FDA 510(k) K243472, 1NEED Pro: https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243472.pdf
  • FDA 510(k) K243143, E-PEN: https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243143.pdf
  • FDA 510(k) K243800, Dermalogica PRO Pen Microneedling System (6883): https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243800.pdf
  • FDA 510(k) K252591, Automatic Micro Needle System (CODE-X): https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252591.pdf
  • FDA 510(k) K202517, Cytrellis Dermal Micro-Coring System: https://www.accessdata.fda.gov/cdrh_docs/pdf20/K202517.pdf
  • FDA 510(k) K252752, ellacor System with Micro-Coring Technology: https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252752.pdf
  • FDA 510(k) K221011, AI.ME System: https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221011.pdf
  • MDPen homepage, meta description (checked 2026-10-06): https://mdpen.co/
  • Zannis Plastic Surgery, “The Rejuvapen Microneedling Treatment” (Google search snippet, 2026-10-06): https://www.zannisplasticsurgery.com/the-rejuvapen-microneedling-treatment/