Is My Microneedling Device FDA-Cleared? Lookup Table
Last checked against the FDA database: October 7, 2026
No microneedling device sold for home use has FDA clearance. All 26 clearances under the FDA’s microneedling product code are for prescription use. Search this page (Ctrl+F) for your device. Every FDA number links to the FDA’s own record. What clearance means →
Popular home-use devices
None of these is FDA-cleared. We searched the FDA’s 510(k) database for each brand by name.
Dr. Pen
No Dr. Pen sold for home use is FDA-cleared. The brand’s only clearance is the A20 (K230420), for prescription use on facial acne scars.
In Canada, Health Canada’s 16 Dec 2021 advisory tells people not to buy or use Dr. Pen pens. Where each model stands:
- Named in the advisory: M8, A6S, A6, A7, A1, X5.
- Not named, but covered: M8S, A10, A8S. The advisory applies to “all models, including but not limited to” those it lists.
- Licensed in Canada: A9, A20. Since 6 Jan 2026 (licence 114618), which lifts the advisory for these models.
- Licence lapsed: A11. The A11 (Ultima Pro) was licensed from 27 Nov 2024 to 9 Dec 2025 (licence 112281). The current licence leaves it off, so the advisory applies again.
Other brands
- Derminator 2: not cleared.
- Dermapen HOME: not cleared. The company’s clearance (K221070) is for the professional DP4, a different device.
- Hydra Pen H2 / H3: not cleared. A Dr. Pen line, now sold as the Dr. Pen H6, so the Health Canada advisory covers it.
- Korabeauticals V2 / V2 Pro: not cleared.
- MDPen / MDPen Ultra: not cleared.
- Banisher 3.0 (stamp): not cleared.
- Dermaroller GmbH rollers: not cleared. The company’s clearance (K241790) is for its XCellarisPRO TWIST pen, not a roller. Its medical rollers are CE-marked in the EU.
- Stacked Skincare roller: not cleared.
- Sdara roller: not cleared.
Microneedling devices with FDA clearance (product code QAI)
Every device in this table is cleared for prescription use only, for the indication shown.
| Device (FDA name) | Company | FDA record | Cleared | Indication |
|---|---|---|---|---|
| SkinPen Precision System | Bellus Medical, LLC | DEN160029 · summary | 2018-03-01 | See the FDA summary. |
| Exceed Microneedling Device | Mt. Derm GmbH | K180778 · summary | 2018-09-07 | The Exceed is a microneedling device and accessories is intended for the treatment of wrinkles in Fitzpatrick skintypes I, II and/or III in the following facial areas: glabellar frown lines, periorbital lines and… |
| Exceed Microneedling device | Mt. Derm GmbH | K182407 · summary | 2019-07-19 | The Exceed 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 and IV in adults aged 22 years or older. |
| Rejuvapen NXT | Refine USA, LLC | K192138 · summary | 2020-04-09 | The Rejuvapen NXT is a microneedling device and accessories intended to be used as a treatment to improve the appearance of periorbital wrinkles in Fitzpatrick skin types I-IV. The Rejuvapen NXT is intended for use… |
| SkinStylus SteriLock MicroSystem | Esthetic Education, LLC | K200044 · summary | 2020-04-10 | The SkinStylus SteriLock® MicroSystem is intended to be used as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older. |
| SkinPen Precision System | Crown Aesthetics | K202243 · summary | 2021-04-02 | 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… |
| MicroPen EVO | Eclipse Medcorp, LLC | K203144 · summary | 2021-05-25 | Indications for Use Form Approved: 0MB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. The Eclipse MicroPen EVO is a microneedling device and accessories intended to be used as a treatment to… |
| Cytrellis Dermal Micro-Coring System | Cytrellis Biosystems, Inc. | K202517 · summary | 2021-07-09 | The Cytrellis Dermal Micro-Coring System is indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with Fitzpatrick… |
| MicroPen EVO | Eclipse Medcorp, LLC | K212558 · summary | 2021-11-24 | The Eclipse MicroPen EVO 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… |
| SkinPen Precision System | Crown Aesthetics | K220506 · summary | 2022-03-07 | 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… |
| Collagen P.I.N. (Percutaneous Induction Needling) | Induction Therapies, LLC | K222199 · summary | 2022-10-21 | The Collagen P.I.N. (Percutaneous Induction Needling) microneedling system is indicated for use as a treatment to improve the appearance of facial acne scars in adults with Fitzpatrick Skin Types I – III, aged 22… |
| AI.ME System | Venus Concept USA, Inc. | K221011 · summary | 2022-12-20 | The AI.ME system is indicated for fractional skin resurfacing. |
| DP4 Microneedling device | Equipmed USA, LLC | K221070 · summary | 2022-12-20 | 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… |
| SkinStylus SteriLock® MicroSystem, Model Number MP1209SL | Esthetic Medical, Inc. | K231073 · summary | 2023-07-28 | The SkinStylus SteriLock® MicroSystem is intended to be used as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older. The SkinStylus… |
| Dr. pen Microneedling System | Guangzhou Ekai Electronic Technology Co., Ltd. | K230420 · summary | 2023-08-11 | The Dr.pen Microneedling System is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years and older. |
| Exceed Unlimited | Mt. Derm GmbH | K233709 · summary | 2024-02-23 | The Exceed Unlimited is a microneedling device and accessories intended for the treatment of wrinkles in Fitzpatrick skin types I, II and/or Ill in the following facial areas: glabellar frown lines, periorbital lines… |
| SkinPen Precision Elite System | Crown Aesthetics | K241400 · summary | 2024-08-29 | See the FDA summary. |
| SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC | K241355 · summary | 2024-10-09 | The SER Pen Carain MicroSystem is intended for use as a treatment to improve the appearance of facial acne scars in adults with Fitzpatrick Skin Types I – III, aged 22 years and older and as a treatment to improve… |
| XCELLARISPRO TWIST microneedling device | Dermaroller GmbH | K241790 · summary | 2025-03-06 | The XCELLARISPRO TWIST microneedling device and accessories is intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types 1, 11, 111 and IV in adults aged 22 years or… |
| 1NEED Pro | Campomats S.R.L. | K243472 · summary | 2025-03-19 | The 1NEED Pro is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years or older. |
| E-PEN (E-PEN) | Bomtech Electronics Co., Ltd. | K243143 · summary | 2025-04-07 | The E-PEN is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years and older. |
| PRO Pen Microneedling System (6883) | Dermalogica, LLC | K243800 · summary | 2025-08-25 | The PRO Pen Microneedling System is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years and older. |
| SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC | K253153 · summary | 2025-10-29 | The SER Pen Carain MicroSystem is intended for use as a treatment to improve the appearance of facial acne scars in adults with Fitzpatrick Skin Types I – III, aged 22 years and older and as a treatment to improve… |
| ellacor System with Micro-Coring Technology | Cytrellis Biosystems, Inc. | K252752 · summary | 2025-10-30 | The ellacor System with Micro-Coring Technology is indicated for use by medical professionals for the treatment of moderate and severe wrinkles in the mid and lower face in adults aged 22 years or older with… |
| SkinStylus SteriLock MicroSystem (MP1209SL) | Esthetic Medical, Inc. | K253002 · summary | 2026-02-19 | The SkinStylus SteriLock® MicroSystem is a microneedling device and accessories intended to be used as a treatment to improve the appearance of periorbital wrinkles in Fitzpatrick skin types I, II, III, IV, V, and VI… |
| Automatic Micro Needle System (CODE-X) | Woorhi Mechatronics Co., Ltd. | K252591 · summary | 2026-05-13 | The Automatic Micro Needle System (CODE-X) is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years or older. |
RF microneedling (product code GEI)
Radiofrequency microneedling systems aren’t cleared as microneedling devices. The FDA clears them as electrosurgical devices (product code GEI), for the uses in each summary. They are professional devices.
| Device (FDA name) | Company | FDA record | Cleared | Use | Indication |
|---|---|---|---|---|---|
| SECRET RF | Ilooda Co,., Ltd. | K170325 · summary | 2017-06-13 | Prescription | SECRET RF is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis. |
| LUTRONIC GENIUS Radiofrequency System | Lutronic Corporation | K180945 · summary | 2018-12-10 | See summary | The LUTRONIC GENIUS Radiofrequency System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. |
| Secret RF Smartcure Applicator with electrodes | Ilooda Co,., Ltd. | K182355 · summary | 2019-09-06 | Prescription | Secret RF Smartcure applicator is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis |
| InMode System with the Morpheus8 (Fractora) Applicators | Inmode MD , Ltd. | K192695 · summary | 2019-12-27 | See summary | See the FDA summary. |
| Potenza | Jeisys Medical Incorporated | K192545 · summary | 2020-02-20 | See summary | The POTENZA is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. |
| SYLFIRM X | VIOL Co., Ltd. | K200185 · summary | 2020-04-22 | See summary | The SYLFIRM X™ is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. |
| InMode System with the Morhpeus8 Applicators | InMode , Ltd. | K200947 · summary | 2020-07-02 | See summary | The InMode System with the Morpheus8 Applicators is intended for use in dermatological procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62 mJ/pin, use of the Morpheus8 (Fractora)… |
| Potenza | Jeisys Medical, Inc. | K201685 · summary | 2021-01-19 | See summary | See the FDA summary. |
| VirtueRF | ShenB Co., Ltd. | K202415 · summary | 2021-01-22 | Prescription | The VirtueRF Electrosurgical System has separate indications for use for each of its functionalities: 1MHz and 2MHz. 1MHz Indications for use Intended for use in dermatologic and general surgical procedures for… |
| VIVACE Electrosurgical Device | ShenB Co., Ltd. | K193070 · summary | 2021-04-26 | See summary | See the FDA summary. |
| Virtue RF | ShenB Co., Ltd. | K211562 · summary | 2021-11-23 | Prescription | See the FDA summary. |
| SYLFIRM X | VIOL Co., Ltd. | K213612 · summary | 2022-06-23 | Prescription | The SYLFIRM XrM is intended for use in dermatologic procedures for electrocoagulation and hemostasis. |
| The InMode System with the Morpheus8 Applicators | InMode , Ltd. | K231790 · summary | 2023-07-20 | See summary | The InMode System with the Morpheus8 Applicators is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62 mJ/pin,… |
| Secret Pro | Ilooda Co,., Ltd. | K233374 · summary | 2023-12-14 | See summary | See the FDA summary. |
| InMode System with the Morpheus8 90 Applicator | InMode , Ltd. | K240017 · summary | 2024-06-13 | See summary | The InMode System with the Morpheus8 90 Applicator is intended for use in dermatological procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62… |
| POTENZA | Jeisys Medical, Inc. | K231287 · summary | 2024-11-05 | Prescription | The POTENZA is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. |
| Secret MAX Multi-platform RF System | Ilooda Co,., Ltd. | K241157 · summary | 2024-11-21 | See summary | The Secret MAX DEEPLUS MENU and SMARTCURE MENU are intended use in dermatologic and general surgical procedures for electro-coagulation and hemostasis. The WAVPLUS MENU is intended for the treatment of the following… |
| POTENZA | Jeisys Medical, Inc. | K231216 · summary | 2024-12-10 | See summary | The POTENZA is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. |
| LUTRONIC GENIUS | Cynosure Lutronic Technology Corporation | K253484 · summary | 2026-06-29 | See summary | See the FDA summary. |
| Potenza Prime | Jeisys Medical Incorporated | K254185 · summary | 2026-09-11 | See summary | See the FDA summary. |
Can’t find your device?
If a device isn’t listed, ask the seller for its K-number and search the FDA 510(k) database. Spotted something wrong or out of date? Tell us, with a source.