FDA Product Code
FDA Product Code QAI — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4430
510(k) Clearances — 26 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252591 | Automatic Micro Needle System (CODE-X) | Woorhi Mechatronics Co., Ltd. | 2026-05-13 | Traditional | PDF ↗ |
| K253002 | SkinStylus SteriLock MicroSystem (MP1209SL) | Esthetic Medical, Inc. | 2026-02-19 | Traditional | PDF ↗ |
| K252752 | ellacor System with Micro-Coring Technology | Cytrellis Biosystems, Inc. | 2025-10-30 | Traditional | PDF ↗ |
| K253153 | SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC | 2025-10-29 | Special | PDF ↗ |
| K243800 | PRO Pen Microneedling System (6883) | Dermalogica, LLC | 2025-08-25 | Traditional | PDF ↗ |
| K243143 | E-PEN (E-PEN) | Bomtech Electronics Co., Ltd. | 2025-04-07 | Traditional | PDF ↗ |
| K243472 | 1NEED Pro | Campomats S.R.L. | 2025-03-19 | Traditional | PDF ↗ |
| K241790 | XCELLARISPRO TWIST microneedling device | Dermaroller GmbH | 2025-03-06 | Traditional | PDF ↗ |
| K241355 | SER Pen Carain MicroSystem (MP1209SP) | Su-Ko Technologies, LLC | 2024-10-09 | Traditional | PDF ↗ |
| K241400 | SkinPen Precision Elite System | Crown Aesthetics | 2024-08-29 | Traditional | PDF ↗ |
| K233709 | Exceed Unlimited | Mt. Derm GmbH | 2024-02-23 | Traditional | PDF ↗ |
| K230420 | Dr. pen Microneedling System | Guangzhou Ekai Electronic Technology Co., Ltd. | 2023-08-11 | Traditional | PDF ↗ |
| K231073 | SkinStylus SteriLock® MicroSystem, Model Number MP1209SL | Esthetic Medical, Inc. | 2023-07-28 | Traditional | PDF ↗ |
| K221070 | DP4 Microneedling device | Equipmed USA, LLC | 2022-12-20 | Traditional | PDF ↗ |
| K221011 | AI.ME System | Venus Concept USA, Inc. | 2022-12-20 | Traditional | PDF ↗ |
| K222199 | Collagen P.I.N. (Percutaneous Induction Needling) | Induction Therapies, LLC | 2022-10-21 | Traditional | PDF ↗ |
| K220506 | SkinPen Precision System | Crown Aesthetics | 2022-03-07 | Special | PDF ↗ |
| K212558 | MicroPen EVO | Eclipse Medcorp, LLC | 2021-11-24 | Traditional | PDF ↗ |
| K202517 | Cytrellis Dermal Micro-Coring System | Cytrellis Biosystems, Inc. | 2021-07-09 | Traditional | PDF ↗ |
| K203144 | MicroPen EVO | Eclipse Medcorp, LLC | 2021-05-25 | Traditional | PDF ↗ |
| K202243 | SkinPen Precision System | Crown Aesthetics | 2021-04-02 | Traditional | PDF ↗ |
| K200044 | SkinStylus SteriLock MicroSystem | Esthetic Education, LLC | 2020-04-10 | Traditional | PDF ↗ |
| K192138 | Rejuvapen NXT | Refine USA, LLC | 2020-04-09 | Traditional | PDF ↗ |
| K182407 | Exceed Microneedling device | Mt. Derm GmbH | 2019-07-19 | Traditional | PDF ↗ |
| K180778 | Exceed Microneedling Device | Mt. Derm GmbH | 2018-09-07 | Traditional | PDF ↗ |
| DEN160029 | SkinPen Precision System | Bellus Medical, LLC | 2018-03-01 | Direct | — |
Product code QAI · Class II · General, Plastic Surgery. Data: openFDA.