Cleared Traditional

MicroPen EVO (K212558) - FDA 510(k) Clearance

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

K212558 · Eclipse Medcorp, LLC · General & Plastic Surgery device
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Nov 2021
Decision
103d
Days
Class 2
Risk

K212558 is an FDA 510(k) clearance for the MicroPen EVO. Classified as Powered Microneedle Device (product code QAI), Class II - Special Controls.

Submitted by Eclipse Medcorp, LLC (The Colony, US). The FDA issued a Cleared decision on November 24, 2021 after a review of 103 days - within the typical 510(k) review window.

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 Eclipse Medcorp, LLC devices

Submission Details

510(k) Number K212558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2021
Decision Date November 24, 2021
Days to Decision 103 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
12d faster than avg
Panel avg: 115d · This submission: 103d
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 K212558.
DP4 Microneedling device
K221070 · Equipmed USA, LLC · Dec 2022
Collagen P.I.N. (Percutaneous Induction Needling)
K222199 · Induction Therapies, LLC · Oct 2022
SkinPen Precision System
K220506 · Crown Aesthetics · Mar 2022
Cytrellis Dermal Micro-Coring System
K202517 · Cytrellis Biosystems, Inc. · Jul 2021
MicroPen EVO
K203144 · Eclipse Medcorp, LLC · May 2021
SkinPen Precision System
K202243 · Crown Aesthetics · Apr 2021