Cleared Traditional

DP4 Microneedling device (K221070) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K221070 · Equipmed USA, LLC · General & Plastic Surgery device
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Dec 2022
Decision
252d
Days
Class 2
Risk

K221070 is an FDA 510(k) clearance for the DP4 Microneedling device. Classified as Powered Microneedle Device (product code QAI), Class II - Special Controls.

Submitted by Equipmed USA, LLC (Newport Beach, US). The FDA issued a Cleared decision on December 20, 2022 after a review of 252 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4430 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Equipmed USA, LLC devices

Submission Details

510(k) Number K221070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2022
Decision Date December 20, 2022
Days to Decision 252 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 115d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QAI Powered Microneedle Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4430
Definition A Powered Microneedle Device Is A Device Using One Or More Needles To Mechanically Puncture And Injure Skin Tissue For Aesthetic Use.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - QAI Powered Microneedle Device

All 25
Devices cleared under the same product code (QAI) and FDA review panel - the closest regulatory comparables to K221070.
Dr. pen Microneedling System
K230420 · Guangzhou Ekai Electronic Technology Co., Ltd. · Aug 2023
SkinStylus SteriLock® MicroSystem, Model Number MP1209SL
K231073 · Esthetic Medical, Inc. · Jul 2023
AI.ME System
K221011 · Venus Concept USA, Inc. · Dec 2022
Collagen P.I.N. (Percutaneous Induction Needling)
K222199 · Induction Therapies, LLC · Oct 2022
SkinPen Precision System
K220506 · Crown Aesthetics · Mar 2022
MicroPen EVO
K212558 · Eclipse Medcorp, LLC · Nov 2021