QAI — Powered Microneedle Device Class II
FDA product code QAI covers "Powered Microneedle Device", a Class II medical device regulated under 21 CFR 878.4430. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- QAI
- Device Class
- Class II
- Regulation Number
- 878.4430
- Submission Type
- 510(k)
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use.
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252591 | Woorhi Mechatronics Co | Automatic Micro Needle System (CODE-X) | May 13, 2026 |
| K253002 | Esthetic Medical | SkinStylus SteriLock MicroSystem (MP1209SL) | Feb 19, 2026 |
| K252752 | Cytrellis Biosystems | ellacor System with Micro-Coring Technology | Oct 30, 2025 |
| K253153 | Su-Ko Technologies | SER Pen Carain MicroSystem (MP1209SP) | Oct 29, 2025 |
| K243800 | Dermalogica | PRO Pen Microneedling System (6883) | Aug 25, 2025 |
| K243143 | Bomtech Electronics Co | E-PEN (E-PEN) | Apr 7, 2025 |
| K243472 | Campomats | 1NEED Pro | Mar 19, 2025 |
| K241790 | Dermaroller | XCELLARISPRO TWIST microneedling device | Mar 6, 2025 |
| K241355 | Su-Ko Technologies | SER Pen Carain MicroSystem (MP1209SP) | Oct 9, 2024 |
| K241400 | Crown Aesthetics | SkinPen Precision Elite System | Aug 29, 2024 |
| K233709 | Mt. Derm | Exceed Unlimited | Feb 23, 2024 |
| K230420 | Guangzhou Ekai Electronic Technology Co | Dr. pen Microneedling System | Aug 11, 2023 |
| K231073 | Esthetic Medical | SkinStylus SteriLock® MicroSystem, Model Number MP1209SL | Jul 28, 2023 |
| K221011 | Venus Concept Usa | AI.ME System | Dec 20, 2022 |
| K221070 | Equipmed Usa | DP4 Microneedling device | Dec 20, 2022 |
| K222199 | Induction Therapies | Collagen P.I.N. (Percutaneous Induction Needling) | Oct 21, 2022 |
| K220506 | Crown Aesthetics | SkinPen Precision System | Mar 7, 2022 |
| K212558 | Eclipse Medcorp | MicroPen EVO | Nov 24, 2021 |
| K202517 | Cytrellis Biosystems | Cytrellis Dermal Micro-Coring System | Jul 9, 2021 |
| K203144 | Eclipse Medcorp | MicroPen EVO | May 25, 2021 |