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
- 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) | February 19, 2026 |
| K252752 | cytrellis biosystems | ellacor System with Micro-Coring Technology | October 30, 2025 |
| K253153 | su-ko technologies | SER Pen Carain MicroSystem (MP1209SP) | October 29, 2025 |
| K243800 | dermalogica | PRO Pen Microneedling System (6883) | August 25, 2025 |
| K243143 | bomtech electronics co | E-PEN (E-PEN) | April 7, 2025 |
| K243472 | campomats | 1NEED Pro | March 19, 2025 |
| K241790 | dermaroller | XCELLARISPRO TWIST microneedling device | March 6, 2025 |
| K241355 | su-ko technologies | SER Pen Carain MicroSystem (MP1209SP) | October 9, 2024 |
| K241400 | crown aesthetics | SkinPen Precision Elite System | August 29, 2024 |
| K233709 | mt. derm | Exceed Unlimited | February 23, 2024 |
| K230420 | guangzhou ekai electronic technology co | Dr. pen Microneedling System | August 11, 2023 |
| K231073 | esthetic medical | SkinStylus SteriLock® MicroSystem, Model Number MP1209SL | July 28, 2023 |
| K221011 | venus concept usa | AI.ME System | December 20, 2022 |
| K221070 | equipmed usa | DP4 Microneedling device | December 20, 2022 |
| K222199 | induction therapies | Collagen P.I.N. (Percutaneous Induction Needling) | October 21, 2022 |
| K220506 | crown aesthetics | SkinPen Precision System | March 7, 2022 |
| K212558 | eclipse medcorp | MicroPen EVO | November 24, 2021 |
| K202517 | cytrellis biosystems | Cytrellis Dermal Micro-Coring System | July 9, 2021 |
| K203144 | eclipse medcorp | MicroPen EVO | May 25, 2021 |