| Automatic Micro Needle System (CODE-X) (K252591) | Woorhi Mechatronics Co., Ltd. | 2026-05-13 |
| SkinStylus SteriLock MicroSystem (MP1209SL) (K253002) | Esthetic Medical, Inc. | 2026-02-19 |
| ellacor System with Micro-Coring Technology (K252752) | Cytrellis Biosystems, Inc. | 2025-10-30 |
| SER Pen Carain MicroSystem (MP1209SP) (K253153) | Su-Ko Technologies, LLC | 2025-10-29 |
| PRO Pen Microneedling System (6883) (K243800) | Dermalogica, LLC | 2025-08-25 |
| E-PEN (E-PEN) (K243143) | Bomtech Electronics Co., Ltd. | 2025-04-07 |
| 1NEED Pro (K243472) | Campomats S.R.L. | 2025-03-19 |
| XCELLARISPRO TWIST microneedling device (K241790) | Dermaroller GmbH | 2025-03-06 |
| SER Pen Carain MicroSystem (MP1209SP) (K241355) | Su-Ko Technologies, LLC | 2024-10-09 |
| SkinPen Precision Elite System (K241400) | Crown Aesthetics | 2024-08-29 |
| Exceed Unlimited (K233709) | Mt. Derm GmbH | 2024-02-23 |
| Dr. pen Microneedling System (K230420) | Guangzhou Ekai Electronic Technology Co., Ltd. | 2023-08-11 |
| SkinStylus SteriLock® MicroSystem, Model Number MP1209SL (K231073) | Esthetic Medical, Inc. | 2023-07-28 |
| DP4 Microneedling device (K221070) | Equipmed USA, LLC | 2022-12-20 |
| AI.ME System (K221011) | Venus Concept USA, Inc. | 2022-12-20 |
| Collagen P.I.N. (Percutaneous Induction Needling) (K222199) | Induction Therapies, LLC | 2022-10-21 |
| SkinPen Precision System (K220506) | Crown Aesthetics | 2022-03-07 |
| MicroPen EVO (K212558) | Eclipse Medcorp, LLC | 2021-11-24 |
| Cytrellis Dermal Micro-Coring System (K202517) | Cytrellis Biosystems, Inc. | 2021-07-09 |
| MicroPen EVO (K203144) | Eclipse Medcorp, LLC | 2021-05-25 |
| SkinPen Precision System (K202243) | Crown Aesthetics | 2021-04-02 |
| SkinStylus SteriLock MicroSystem (K200044) | Esthetic Education, LLC | 2020-04-10 |
| Rejuvapen NXT (K192138) | Refine USA, LLC | 2020-04-09 |
| Exceed Microneedling device (K182407) | Mt. Derm GmbH | 2019-07-19 |
| Exceed Microneedling Device (K180778) | Mt. Derm GmbH | 2018-09-07 |
| SkinPen Precision System (DEN160029) | Bellus Medical, LLC | 2018-03-01 |