DeviceClearance

Product code QAI— General, Plastic Surgery

SkinPen Precision System

Classification name
Powered Microneedle Device
Device class
Class 2
Regulation
21 CFR 878.4430
Advisory panel
General, Plastic Surgery
Total cleared
26
First cleared
Most recent

FDA classification definition

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

— U.S. Food and Drug Administration, device classification record for product code QAI under 21 CFR 878.4430, via openFDA

Market context for product code QAI

FDA has cleared 26 devices under product code QAI between 2018 and 2026, filed by 18 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QAI

Recent clearances under product code QAI

Data sourced from openFDA. This site is unofficial and independent of the FDA.