FDA product code QAI

Powered Microneedle Device

General, Plastic Surgery·Class 2·21 CFR 878.4430
US regulatory classifications
US Product Code (FDA)
QAI
View Product Code Classification →
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.4430
View CFR Regulation →
Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

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

Search keywords
About this record

Powered Microneedle Device is a medical device type in the General, Plastic Surgery specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.