QAI · Class II · 21 CFR 878.4430

FDA Product Code QAI: Powered Microneedle Device

A Powered Microneedle Device Is A Device Using One Or More Needles To Mechanically Puncture And Injure Skin Tissue For Aesthetic Use.

Leading manufacturers include Mt. Derm GmbH, Crown Aesthetics and Su-Ko Technologies, LLC.

26
Total
25
Cleared
188d
Avg days
2018
Since
Growing category - 10 submissions in the last 2 years vs 6 in the prior period
Review times improving: avg 161d recently vs 205d historically

FDA 510(k) Cleared Powered Microneedle Device Devices (Product Code QAI)

26 devices
1–24 of 26
Cleared May 13, 2026
Automatic Micro Needle System (CODE-X)
K252591
Woorhi Mechatronics Co., Ltd.
General & Plastic Surgery · 271d
Cleared Feb 19, 2026
SkinStylus SteriLock MicroSystem (MP1209SL)
K253002
Esthetic Medical, Inc.
General & Plastic Surgery · 153d
Cleared Oct 30, 2025
ellacor System with Micro-Coring Technology
K252752
Cytrellis Biosystems, Inc.
General & Plastic Surgery · 62d
Cleared Oct 29, 2025
SER Pen Carain MicroSystem (MP1209SP)
K253153
Su-Ko Technologies, LLC
General & Plastic Surgery · 33d
Cleared Aug 25, 2025
PRO Pen Microneedling System (6883)
K243800
Dermalogica, LLC
General & Plastic Surgery · 257d
Cleared Apr 07, 2025
E-PEN (E-PEN)
K243143
Bomtech Electronics Co., Ltd.
General & Plastic Surgery · 189d
Cleared Mar 19, 2025
1NEED Pro
K243472
Campomats S.R.L.
General & Plastic Surgery · 131d
Cleared Mar 06, 2025
XCELLARISPRO TWIST microneedling device
K241790
Dermaroller GmbH
General & Plastic Surgery · 258d
Cleared Oct 09, 2024
SER Pen Carain MicroSystem (MP1209SP)
K241355
Su-Ko Technologies, LLC
General & Plastic Surgery · 148d
Cleared Aug 29, 2024
SkinPen Precision Elite System
K241400
Crown Aesthetics
General & Plastic Surgery · 104d
Cleared Feb 23, 2024
Exceed Unlimited
K233709
Mt. Derm GmbH
General & Plastic Surgery · 95d
Cleared Aug 11, 2023
Dr. pen Microneedling System
K230420
Guangzhou Ekai Electronic Technology Co., Ltd.
General & Plastic Surgery · 176d
Cleared Jul 28, 2023
SkinStylus SteriLock® MicroSystem, Model Number MP1209SL
K231073
Esthetic Medical, Inc.
General & Plastic Surgery · 105d
Cleared Dec 20, 2022
AI.ME System
K221011
Venus Concept USA, Inc.
General & Plastic Surgery · 259d
Cleared Dec 20, 2022
DP4 Microneedling device
K221070
Equipmed USA, LLC
General & Plastic Surgery · 252d
Cleared Oct 21, 2022
Collagen P.I.N. (Percutaneous Induction Needling)
K222199
Induction Therapies, LLC
General & Plastic Surgery · 91d
Cleared Mar 07, 2022
SkinPen Precision System
K220506
Crown Aesthetics
General & Plastic Surgery · 13d
Cleared Nov 24, 2021
MicroPen EVO
K212558
Eclipse Medcorp, LLC
General & Plastic Surgery · 103d
Cleared Jul 09, 2021
Cytrellis Dermal Micro-Coring System
K202517
Cytrellis Biosystems, Inc.
General & Plastic Surgery · 311d
Cleared May 25, 2021
MicroPen EVO
K203144
Eclipse Medcorp, LLC
General & Plastic Surgery · 216d
Cleared Apr 02, 2021
SkinPen Precision System
K202243
Crown Aesthetics
General & Plastic Surgery · 235d
Cleared Apr 10, 2020
SkinStylus SteriLock MicroSystem
K200044
Esthetic Education, LLC
General & Plastic Surgery · 93d
Cleared Apr 09, 2020
Rejuvapen NXT
K192138
Refine USA, LLC
General & Plastic Surgery · 245d
Cleared Jul 19, 2019
Exceed Microneedling device
K182407
Mt. Derm GmbH
General & Plastic Surgery · 318d

About Product Code QAI - Regulatory Context

510(k) Submission Activity

26 total 510(k) submissions under product code QAI since 2018, with 25 receiving FDA clearance (average review time: 188 days).

Submission volume has increased in recent years - 10 submissions in the last 24 months compared to 6 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - QAI Product Code

Recent submissions under QAI have taken an average of 161 days to reach a decision - down from 205 days historically, suggesting improved FDA processing for this classification.

QAI devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →