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Panels › General, Plastic Surgery › Product code QAI · Class 2

Powered Microneedle Device

Regulation 878.4430

2510(k)s in 12 months (26 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
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Top companies in QAI

Company510(k)sRecalls
Cytrellis Biosystems, Inc.22
Crown Aesthetics30
Mt. Derm GmbH30
Bellus Medical, LLC11
Eclipse Medcorp, LLC20
Esthetic Medical, Inc.20
Su-Ko Technologies, LLC20
Bomtech Electronics Co., Ltd.10
Campomats S.R.L.10
Dermalogica, LLC10
Decided510(k)Device and applicantCode
May 13, 2026K252591Automatic Micro Needle System (CODE-X)
Woorhi Mechatronics Co., Ltd., KR
QAI
Feb 19, 2026K253002SkinStylus SteriLock MicroSystem (MP1209SL)
Esthetic Medical, Inc.
QAI
Oct 30, 2025K252752ellacor System with Micro-Coring Technology
Cytrellis Biosystems, Inc.
QAI
Oct 29, 2025K253153SER Pen Carain MicroSystem (MP1209SP)
Su-Ko Technologies, LLC
QAI
Aug 25, 2025K243800PRO Pen Microneedling System (6883)
Dermalogica, LLC
QAI
Apr 7, 2025K243143E-PEN (E-PEN)
Bomtech Electronics Co., Ltd., KR
QAI
Mar 19, 2025K2434721NEED Pro
Campomats S.R.L., IT
QAI
Mar 6, 2025K241790XCELLARISPRO TWIST microneedling device
Dermaroller GmbH, DE
QAI
Oct 9, 2024K241355SER Pen Carain MicroSystem (MP1209SP)
Su-Ko Technologies, LLC
QAI
Aug 29, 2024K241400SkinPen Precision Elite System
Crown Aesthetics
QAI
Feb 23, 2024K233709Exceed Unlimited
Mt. Derm GmbH, DE
QAI
Aug 11, 2023K230420Dr. pen Microneedling System
Guangzhou Ekai Electronic Technology Co., Ltd., CN
QAI
Jul 28, 2023K231073SkinStylus SteriLock® MicroSystem, Model Number MP1209SL
Esthetic Medical, Inc.
QAI
Dec 20, 2022K221070DP4 Microneedling device
Equipmed USA, LLC
QAI
Dec 20, 2022K221011AI.ME System
Venus Concept USA, Inc.
QAI
Oct 21, 2022K222199Collagen P.I.N. (Percutaneous Induction Needling)
Induction Therapies, LLC
QAI
Mar 7, 2022K220506SkinPen Precision System
Crown Aesthetics
QAI
Nov 24, 2021K212558MicroPen EVO
Eclipse Medcorp, LLC
QAI
Jul 9, 2021K202517Cytrellis Dermal Micro-Coring System
Cytrellis Biosystems, Inc.
QAI
May 25, 2021K203144MicroPen EVO
Eclipse Medcorp, LLC
QAI
Apr 2, 2021K202243SkinPen Precision System
Crown Aesthetics
QAI
Apr 10, 2020K200044SkinStylus SteriLock MicroSystem
Esthetic Education, LLC
QAI
Apr 9, 2020K192138Rejuvapen NXT
Refine USA, LLC
QAI
Jul 19, 2019K182407Exceed Microneedling device
Mt. Derm GmbH, DE
QAI
Sep 7, 2018K180778Exceed Microneedling Device
Mt. Derm GmbH, DE
QAI
Mar 1, 2018DEN160029SkinPen Precision System
Bellus Medical, LLC
QAI

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