FDA 510(k) Applications for Medical Device Product Code "QAI"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| DEN160029 | BELLUS MEDICAL, LLC. | SkinPen Precision System | 03/01/2018 |
| K243143 | BOMTECH ELECTRONICS CO., LTD. | E-PEN (E-PEN) | 04/07/2025 |
| K243472 | Campomats S.r.l. | 1NEED Pro | 03/19/2025 |
| K241400 | Crown Aesthetics | SkinPen Precision Elite System | 08/29/2024 |
| K202243 | Crown Aesthetics | SkinPen Precision System | 04/02/2021 |
| K220506 | Crown Aesthetics | SkinPen Precision System | 03/07/2022 |
| K202517 | Cytrellis Biosystems, Inc. | Cytrellis Dermal Micro-Coring System | 07/09/2021 |
| K241790 | Dermaroller GmbH | XCELLARISPRO TWIST microneedling device | 03/06/2025 |
| K212558 | Eclipse Medcorp LLC | MicroPen EVO | 11/24/2021 |
| K203144 | Eclipse MedCorp, LLC | MicroPen EVO | 05/25/2021 |
| K221070 | Equipmed USA LLC | DP4 Microneedling device | 12/20/2022 |
| K200044 | Esthetic Education LLC | SkinStylus SteriLock MicroSystem | 04/10/2020 |
| K231073 | Esthetic Medical Inc. | SkinStylus SteriLock« MicroSystem, Model Number MP1209SL | 07/28/2023 |
| K230420 | Guangzhou Ekai Electronic Technology Co., Ltd. | Dr. pen Microneedling System | 08/11/2023 |
| K222199 | Induction Therapies LLC | Collagen P.I.N. (Percutaneous Induction Needling) | 10/21/2022 |
| K182407 | Mt. Derm GmbH | Exceed Microneedling device | 07/19/2019 |
| K180778 | MT.DERM GmbH | Exceed Microneedling Device | 09/07/2018 |
| K233709 | Mt.Derm GmbH | Exceed Unlimited | 02/23/2024 |
| K192138 | Refine USA LLC | Rejuvapen NXT | 04/09/2020 |
| K241355 | Su-Ko Technologies LLC | SER Pen Carain MicroSystem (MP1209SP) | 10/09/2024 |
| K221011 | Venus Concept USA Inc. | AI.ME System | 12/20/2022 |
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