Every FDA Microneedling Clearance Since January 2025

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The FDA cleared eight microneedling devices under product code QAI between March 6, 2025 and May 13, 2026, the most recent decision on record. Every one is a prescription device. None was cleared for over-the-counter or home use, and four of the eight are cleared for one indication only: improving the appearance of facial acne scars in adults 22 or older.

Three of them, from three different companies, name the Dr. Pen A20 as the device they are substantially equivalent to.

The eight clearances

All eight decisions read “Substantially Equivalent” in the FDA’s 510(k) database. Indications are condensed from each device’s indications-for-use statement; the full wording is in the summaries listed under Sources.

Decision date Device (510(k)) Applicant Cleared to improve the appearance of Predicate named
Mar 6, 2025 XCellarisPRO TWIST (K241790) Dermaroller GmbH Facial acne scars, Fitzpatrick I–IV; wrinkles (glabellar frown lines, periorbital lines, cheek folds), Fitzpatrick I–III; adults 22+ Exceed (K182407, K180778), SkinPen Precision (DEN160029)
Mar 19, 2025 1NEED Pro (K243472) Campomats S.R.L. Facial acne scars, adults 22+ Dr. pen Microneedling System (K230420)
Apr 7, 2025 E-PEN (K243143) Bomtech Electronics Co., Ltd. Facial acne scars, adults 22+ SkinPen Precision (DEN160029)
Aug 25, 2025 PRO Pen Microneedling System (K243800) Dermalogica, LLC Facial acne scars, adults 22+ Dr. Pen Microneedling System (K230420)
Oct 29, 2025 SER Pen Carain MicroSystem (K253153) Su-Ko Technologies, LLC Facial acne scars, Fitzpatrick I–III, and surgical or traumatic hypertrophic scars on the abdomen; adults 22+ SER Pen Carain MicroSystem (K241355)
Oct 30, 2025 ellacor System with Micro-Coring Technology (K252752) Cytrellis Biosystems, Inc. Moderate and severe wrinkles in the mid and lower face (treatment “by medical professionals”), Fitzpatrick I–IV, adults 22+; also fractional skin resurfacing Cytrellis Dermal Micro-Coring System (K202517)
Feb 19, 2026 SkinStylus SteriLock MicroSystem (K253002) Esthetic Medical, Inc. Periorbital wrinkles, Fitzpatrick I–VI, adults 34+ Exceed (K180778)
May 13, 2026 Automatic Micro Needle System, CODE-X (K252591) Woorhi Mechatronics Co., Ltd. Facial acne scars, adults 22+ Dr.pen Microneedling System (K230420)

The Dr. Pen A20 as a predicate

K230420 is the 510(k) the FDA granted Guangzhou Ekai Electronic Technology Co., Ltd. on August 11, 2023 for the “Dr. pen Microneedling System”, model A20, for prescription use on facial acne scars. Three of the eight summaries list it as the predicate:

  • 1NEED Pro (Campomats): “Legally Marketed Predicate Devices … K230420 Dr.pen Microneedling System”.
  • PRO Pen (Dermalogica): “Predicate #: K230420 Name: Dr. Pen Microneedling System”. The summary says the PRO Pen is identical to the predicate in its indications and several technical characteristics, and differs in an optional mains-power adapter, a 1.5 mm maximum depth against the predicate’s 2.0 mm, and a 3-year cartridge shelf life against 2 years.
  • CODE-X (Woorhi Mechatronics): “Primary Predicate • K230420, Dr.pen Microneedling System by GC AMERICA INC. (Guangzhou Ekai Electronic Technology Co., Ltd.)”. It adds that “clinical testing was not necessary to establish substantial equivalency.”

A predicate is the already-cleared device a new one is compared against. Being named as one says nothing about how the Dr. Pen A20 performs; it means the FDA accepted three later pens as substantially equivalent to it. Our Dr. Pen A20 review covers what the A20’s own clearance does and does not include.

Two that are not standard needle pens

ellacor removes skin rather than only puncturing it: its summary describes “excising full thickness micro-columns of the dermal and epidermal tissue via specially designed hollow coring needles”. Its predicate is Cytrellis’s own 2021 device, and the summary reports a single-center histology study in patients undergoing abdominoplasty.

SER Pen (K253153) is a Special 510(k), filed as a “Design Modification” of the company’s own cleared SER Pen. The summary lists the changes as a powered 7-speed control head with a corded power option and a modified cartridge (T2.0). The original SER Pen clearance, K241355, dates from October 9, 2024.

SkinStylus reports a clinical study of its own: a single-arm study at two centers on facial wrinkles, which the summary says supports an age group (34+) and skin-type range (I–VI) that differ from its predicate’s. By contrast, the XCellarisPRO TWIST summary says “No clinical studies were performed”, and the CODE-X summary says clinical testing “was not necessary”.

What it means for buyers

  • Prescription use means sold to, or on the order of, a licensed practitioner. None of these clearances covers a pen bought for use at home.
  • A clearance covers the named model. A seller describing a different model, or a whole brand, as “FDA-approved” is not describing any of these records. Our FDA lookup lists every cleared microneedling device by name and number.
  • The cleared pens are professional devices. Our professional pens page reviews them.

RF microneedling systems are cleared under a different product code (GEI) and are not in this list; see our RF microneedling page.

No company response was sought: this post reports regulator records.

Last updated: October 6, 2026. 510(k) records checked against openFDA (data last updated September 28, 2026).

Sources

  • openFDA 510(k) API, product code QAI, decisions January 1, 2025 to date (checked 2026-10-06, 8 results): https://api.fda.gov/device/510k.json?search=product_code:QAI+AND+decision_date:[2025-01-01+TO+2026-12-31]&limit=100
  • K241790, XCellarisPRO TWIST, 510(k) summary: https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241790.pdf
  • K243472, 1NEED Pro, 510(k) summary: https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243472.pdf
  • K243143, E-PEN, 510(k) summary: https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243143.pdf
  • K243800, PRO Pen Microneedling System, 510(k) summary: https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243800.pdf
  • K253153, SER Pen Carain MicroSystem, Special 510(k) summary: https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253153.pdf
  • K252752, ellacor System with Micro-Coring Technology, 510(k) summary: https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252752.pdf
  • K253002, SkinStylus SteriLock MicroSystem, 510(k) summary: https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253002.pdf
  • K252591, Automatic Micro Needle System (CODE-X), 510(k) summary: https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252591.pdf
  • K230420, Dr. pen Microneedling System, 510(k) summary: https://www.accessdata.fda.gov/cdrh_docs/pdf23/K230420.pdf
  • K241355, SER Pen Carain MicroSystem, 510(k) summary: https://www.accessdata.fda.gov/cdrh_docs/pdf24/K241355.pdf
  • 21 CFR 801.109, prescription devices: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-D/section-801.109

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