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 Esthetic Medical, Inc..

1
Total
1
Cleared
153d
Avg days
2026
Since

FDA 510(k) Cleared Powered Microneedle Device Devices (Product Code QAI)

1 devices
1–1 of 1

How to use this database

This page lists all FDA 510(k) submissions for Powered Microneedle Device devices (product code QAI). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the General & Plastic Surgery FDA review panel. Browse all General & Plastic Surgery devices →