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QAI — Powered Microneedle Device Class II

FDA Device Classification

Classification Details

Product Code
QAI
Device Class
Class II
Regulation Number
878.4430
Submission Type
Review Panel
SU
Medical Specialty
General, Plastic Surgery
Implant
No

Definition

A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K253002esthetic medicalSkinStylus SteriLock MicroSystem (MP1209SL)February 19, 2026
K252752cytrellis biosystemsellacor System with Micro-Coring TechnologyOctober 30, 2025
K253153su-ko technologiesSER Pen Carain MicroSystem (MP1209SP)October 29, 2025
K243800dermalogicaPRO Pen Microneedling System (6883)August 25, 2025
K243143bomtech electronics coE-PEN (E-PEN)April 7, 2025
K243472campomats1NEED ProMarch 19, 2025
K241790dermarollerXCELLARISPRO TWIST microneedling deviceMarch 6, 2025
K241355su-ko technologiesSER Pen Carain MicroSystem (MP1209SP)October 9, 2024
K241400crown aestheticsSkinPen Precision Elite SystemAugust 29, 2024
K233709mt. dermExceed UnlimitedFebruary 23, 2024
K230420guangzhou ekai electronic technology coDr. pen Microneedling SystemAugust 11, 2023
K231073esthetic medicalSkinStylus SteriLock® MicroSystem, Model Number MP1209SLJuly 28, 2023
K221070equipmed usaDP4 Microneedling deviceDecember 20, 2022
K221011venus concept usaAI.ME SystemDecember 20, 2022
K222199induction therapiesCollagen P.I.N. (Percutaneous Induction Needling)October 21, 2022
K220506crown aestheticsSkinPen Precision SystemMarch 7, 2022
K212558eclipse medcorpMicroPen EVONovember 24, 2021
K202517cytrellis biosystemsCytrellis Dermal Micro-Coring SystemJuly 9, 2021
K203144eclipse medcorpMicroPen EVOMay 25, 2021
K202243crown aestheticsSkinPen Precision SystemApril 2, 2021