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 Cytrellis Biosystems, Inc..

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 →