510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QAIClass II

Powered Microneedle Device

21 CFR 878.4430 / General, Plastic Surgery
FDA source (opens on fda.gov)

QAI is the FDA product code for Powered Microneedle Device, a class II device type, regulated under 21 CFR 878.4430. FDA's definition for this code reads: "A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use". As of , FDA records hold 26 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
QAI
Device name
Powered Microneedle Device
FDA definition
A powered microneedle device is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use.
Regulation
21 CFR 878.4430
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
26
Ingested recalls
3

Clearances, product code QAI

By decision year
26 clearances under product code QAI with a decision year between 2018 and 2026, 2025 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code QAI by decision year
YearClearances
20182
20191
20202
20214
20224
20232
20243
20256
20262

Applicants with the most clearances

Product code QAI
Applicants holding the most 510(k) clearances under product code QAI
ApplicantClearances
Crown Aesthetics3
Mt. Derm GmbH3
Cytrellis Biosystems, Inc.2
Eclipse Medcorp, LLC2
Esthetic Medical, Inc.2
SU-KO Technologies LLC2
Bellus Medical, LLC1
Bomtech Electronics Co., Ltd.1
Campomats1
Dermalogica, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 60 companies shown, in name order