Product code QAI
- Device name
- Powered Microneedle Device
- Medical specialty
- General, Plastic Surgery
- Device class
- 2
- Regulation number
- 878.4430
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252591 | Automatic Micro Needle System (CODE-X) | Woorhi Mechatronics Co., Ltd. | 2026-05-13 |
| K253002 | SkinStylus SteriLock MicroSystem (MP1209SL) | Esthetic Medical, Inc. | 2026-02-19 |
| K252752 | ellacor System with Micro-Coring Technology | Cytrellis Biosystems, Inc. | 2025-10-30 |
| K253153 | SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC | 2025-10-29 |
| K243800 | PRO Pen Microneedling System (6883) | Dermalogica, LLC | 2025-08-25 |
| K243143 | E-PEN (E-PEN) | Bomtech Electronics Co., Ltd. | 2025-04-07 |
| K243472 | 1NEED Pro | Campomats S.R.L. | 2025-03-19 |
| K241790 | XCELLARISPRO TWIST microneedling device | Dermaroller GmbH | 2025-03-06 |
| K241355 | SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC | 2024-10-09 |
| K241400 | SkinPen Precision Elite System | Crown Aesthetics | 2024-08-29 |
| K233709 | Exceed Unlimited | Mt. Derm GmbH | 2024-02-23 |
| K230420 | Dr. pen Microneedling System | Guangzhou Ekai Electronic Technology Co., Ltd. | 2023-08-11 |
| K231073 | SkinStylus SteriLock® MicroSystem, Model Number MP1209SL | Esthetic Medical, Inc. | 2023-07-28 |
| K221070 | DP4 Microneedling device | Equipmed USA, LLC | 2022-12-20 |
| K221011 | AI.ME System | Venus Concept USA, Inc. | 2022-12-20 |
| K222199 | Collagen P.I.N. (Percutaneous Induction Needling) | Induction Therapies, LLC | 2022-10-21 |
| K220506 | SkinPen Precision System | Crown Aesthetics | 2022-03-07 |
| K212558 | MicroPen EVO | Eclipse Medcorp, LLC | 2021-11-24 |
| K202517 | Cytrellis Dermal Micro-Coring System | Cytrellis Biosystems, Inc. | 2021-07-09 |
| K203144 | MicroPen EVO | Eclipse Medcorp, LLC | 2021-05-25 |
| K202243 | SkinPen Precision System | Crown Aesthetics | 2021-04-02 |
| K200044 | SkinStylus SteriLock MicroSystem | Esthetic Education, LLC | 2020-04-10 |
| K192138 | Rejuvapen NXT | Refine USA, LLC | 2020-04-09 |
| K182407 | Exceed Microneedling device | Mt. Derm GmbH | 2019-07-19 |
| K180778 | Exceed Microneedling Device | Mt. Derm GmbH | 2018-09-07 |
| DEN160029 | SkinPen Precision System | Bellus Medical, LLC | 2018-03-01 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| EMTDEMNPEY06USMP0 | 6-MNP 1.5 Exceed II 3.0 | MT.DERM GmbH | 2026-05-22 |
| EMTDAD64901USMP0 | Bio Touch Precision | MT.DERM GmbH | 2026-05-22 |
| EMTDCF104901USMP0 | Bio Touch Aero | MT.DERM GmbH | 2026-05-22 |
| EMTDCG100206USMP0 | Exceed Unlimited | MT.DERM GmbH | 2026-05-22 |
| EMTDEMNPA4806USAMP0 | 6-MNP 1.5 ToskaniMED USA | MT.DERM GmbH | 2026-05-22 |
| EMTDEMNPA4906USMP0 | 6-MNP 1.5 Exceed US | MT.DERM GmbH | 2026-05-22 |
| EMTDEMNPEX4906USMP0 | 6-MNP 1.5 Exceed II 2.0 | MT.DERM GmbH | 2026-05-22 |
| 08800016000443 | E-PEN | BOMTECH ELECTRONICS CO., LTD. | 2026-04-29 |
| 00860015460646 | LuxPen Microneedling Cartridges | T AESTHETICS LLC | 2026-03-20 |
| 00860015460608 | LuxPen | T AESTHETICS LLC | 2026-03-12 |
| 00666151621244 | PRO Pen 14-Pin Microneedling Cartridge | Dermalogica, LLC | 2026-01-31 |
| 00666151621305 | PRO Pen Microneedling System | Dermalogica, LLC | 2026-01-31 |
| B933ELKIT04 | ellacor | Cytrellis Biosystems, Inc. | 2025-12-16 |
| 08055598060075 | 1NEED Pro Cartridges | CAMPOMATS SRL | 2025-12-03 |
| 08055598060068 | 1NEED Pro | CAMPOMATS SRL | 2025-12-03 |
| B933ELSYS02R0 | ellacor | Cytrellis Biosystems, Inc. | 2025-10-20 |
| 04260446131058 | XCELLARISPRO barrier sleeve | Dermaroller GmbH | 2025-08-26 |
| B933ELCCV011 | Ellacor | Cytrellis Biosystems, Inc. | 2024-11-01 |
| 00850060751028 | SkinPen Precision Elite | Bellus Medical, LLC | 2024-10-01 |
| B933EL03N021 | Ellacor | Cytrellis Biosystems, Inc. | 2024-09-12 |
| EMTDEMNPA4806USMP0 | Safety Needle Cartridge 6-MNP 1.5 Exceed US | MT.DERM GmbH | 2024-01-10 |
| EMTDAD64801USMP1 | Exceed | MT.DERM GmbH | 2024-01-10 |
| EMTD104802USMP0 | Footswitch | MT.DERM GmbH | 2024-01-10 |
| 08720261027074 | Dp4 | Equipmed USA B.V. | 2023-04-21 |
| 08720261026428 | Dp4 | Equipmed USA B.V. | 2023-04-21 |
| 00850035498279 | SP MicroPen EVO Microneedling Cartridge | Bellus Medical, LLC | 2022-05-25 |
| 00850035498262 | SP MicroPen EVO | Bellus Medical, LLC | 2022-05-25 |
| 00853602008390 | Eclipse EVO Microneedling Cartridge | ECLIPSE | 2022-01-11 |
| B933ELCCV010 | Ellacor | Cytrellis Biosystems, Inc. | 2021-09-30 |
| EMTDEMNPA4206USMP0 | Safety Needle Cartridge 6-MNP 1.5 Exceed US | MT.DERM GmbH | 2020-01-01 |