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FDA PRODUCT CODE · CLASS II

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.

DEVICE CLASS
Class II
REGULATION
21 CFR 878.4430
MEDICAL SPECIALTY
General, Plastic Surgery
REVIEW PANEL
SU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
9
510(K)/PMA CLEARANCES
510k: 9
0
RECALL ENTRIES

Recent clearances

K252591Woorhi Mechatronics Co., Ltd. · 510k2026-05-13
K253002Esthetic Medical, Inc. · 510k2026-02-19
K252752Cytrellis Biosystems, Inc. · 510k2025-10-30
K253153Su-Ko Technologies, LLC · 510k2025-10-29
K243800Dermalogica, LLC · 510k2025-08-25
K243143Bomtech Electronics Co., Ltd. · 510k2025-04-07
K243472Campomats S.R.L. · 510k2025-03-19
K241790Dermaroller GmbH · 510k2025-03-06

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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