QAI
- Product code
- QAI
- Device name
- Powered Microneedle Device
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.4430
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 26
FDA classification definition
A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use.
510(k) clearances, last 3 years (11)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252591 | 2026-05-13 | Woorhi Mechatronics Co., Ltd. | Automatic Micro Needle System (CODE-X) | |
| K253002 | 2026-02-19 | Esthetic Medical, Inc. | SkinStylus SteriLock MicroSystem (MP1209SL) | |
| K252752 | 2025-10-30 | Cytrellis Biosystems, Inc. | ellacor System with Micro-Coring Technology | |
| K253153 | 2025-10-29 | Su-Ko Technologies, LLC | SER Pen Carain MicroSystem (MP1209SP) | |
| K243800 | 2025-08-25 | Dermalogica, LLC | PRO Pen Microneedling System (6883) | |
| K243143 | 2025-04-07 | Bomtech Electronics Co., Ltd. | E-PEN (E-PEN) | |
| K243472 | 2025-03-19 | Campomats S.R.L. | 1NEED Pro | |
| K241790 | 2025-03-06 | Dermaroller GmbH | XCELLARISPRO TWIST microneedling device | |
| K241355 | 2024-10-09 | Su-Ko Technologies, LLC | SER Pen Carain MicroSystem (MP1209SP) | FDA |
| K241400 | 2024-08-29 | Crown Aesthetics | SkinPen Precision Elite System | |
| K233709 | 2024-02-23 | Mt. Derm GmbH | Exceed Unlimited |
Official FDA classification page: QAI
Classification and pathway per current FDA publications. Data from openFDA (CC0).