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 Crown Aesthetics, Cytrellis Biosystems, Inc. and Eclipse Medcorp, LLC.
FDA 510(k) Cleared Powered Microneedle Device Devices (Product Code QAI)
About Product Code QAI - Regulatory Context
510(k) Submission Activity
25 total 510(k) submissions under product code QAI since 2018, with 24 receiving FDA clearance (average review time: 185 days).
Submission volume has increased in recent years - 9 submissions in the last 24 months compared to 6 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QAI have taken an average of 148 days to reach a decision - down from 205 days historically, suggesting improved FDA processing for this classification.
QAI devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →