FDA product code QAI: Powered Microneedle Device
QAI is the FDA product code for powered microneedle device. It is a Class II device, regulated under 21 CFR 878.4430 and reviewed by the General and Plastic Surgery panel. FDA has cleared 25 510(k) submissions under QAI, 17 in the last five years, from 17 different applicants. The average 510(k) review took 171 days (median 165); 161 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 3 recalls for QAI devices, 2 initiated in the last five years.
Definition
A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use.
Classification
| Field | Value |
|---|---|
| Device name | Powered Microneedle Device |
| Device class | Class II |
| Regulation | 21 CFR 878.4430 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
510(k) clearances per year for QAI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 165 |
| 2019 | 1 | 318 |
| 2020 | 2 | 169 |
| 2021 | 4 | 216 |
| 2022 | 4 | 154 |
| 2023 | 2 | 140 |
| 2024 | 3 | 116 |
| 2025 | 6 | 155 |
| 2026 | 2 | 212 |
Compare with all 510(k) review times · Search every QAI clearance
Top QAI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Crown Aesthetics | 3 | 2024-08-29 |
| Mt. Derm GmbH | 3 | 2024-02-23 |
| Esthetic Medical, Inc. | 2 | 2026-02-19 |
| Cytrellis Biosystems, Inc. | 2 | 2025-10-30 |
| Su-Ko Technologies, LLC | 2 | 2025-10-29 |
12 more applicants have QAI clearances. See the full list in Caduvo.
Most recent QAI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K252591 | Woorhi Mechatronics Co., Ltd. | Automatic Micro Needle System (CODE-X) | 2026-05-13 | 271 |
| K253002 | Esthetic Medical, Inc. | SkinStylus SteriLock MicroSystem (MP1209SL) | 2026-02-19 | 153 |
| K252752 | Cytrellis Biosystems, Inc. | ellacor System with Micro-Coring Technology | 2025-10-30 | 62 |
| K253153 | Su-Ko Technologies, LLC | SER Pen Carain MicroSystem (MP1209SP) | 2025-10-29 | 33 |
| K243800 | Dermalogica, LLC | PRO Pen Microneedling System (6883) | 2025-08-25 | 257 |
Recalls for QAI devices
3 product recalls in 3 recall events; 2 initiated in the last five years and 1 still open. Most recent: 2023-06-23.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2023 | 2 |
Frequently asked questions
What is FDA product code QAI?
QAI is the FDA product code for powered microneedle device. It is a Class II device, regulated under 21 CFR 878.4430 and reviewed by the General and Plastic Surgery panel.
What device class is QAI?
Class II, regulation 21 CFR 878.4430. Typical premarket route: 510(k).
How long does a 510(k) take for product code QAI?
Across 25 cleared submissions the average was 171 days from receipt to decision (median 165).
Which companies have the most QAI clearances?
Crown Aesthetics (3); Mt. Derm GmbH (3); Esthetic Medical, Inc. (2); Cytrellis Biosystems, Inc. (2); Su-Ko Technologies, LLC (2).
Have QAI devices been recalled?
Yes: 3 product recalls across 3 recall events; the most recent began 2023-06-23.
Next steps
- Run an FDA pathway report with predicate devices for product code QAI
- Run a recall and safety report across every QAI manufacturer
- Watch product code QAI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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