Cleared Traditional

Exceed Microneedling device (K182407) - FDA 510(k) Clearance

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

K182407 · Mt. Derm GmbH · General & Plastic Surgery device
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Jul 2019
Decision
318d
Days
Class 2
Risk

K182407 is an FDA 510(k) clearance for the Exceed Microneedling device. Classified as Powered Microneedle Device (product code QAI), Class II - Special Controls.

Submitted by Mt. Derm GmbH (Berlin, DE). The FDA issued a Cleared decision on July 19, 2019 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Mt. Derm GmbH devices

Submission Details

510(k) Number K182407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 2018
Decision Date July 19, 2019
Days to Decision 318 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
203d slower than avg
Panel avg: 115d · This submission: 318d
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 Consultant

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Susan D'Arcy

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K182407.
SkinPen Precision System
K202243 · Crown Aesthetics · Apr 2021
SkinStylus SteriLock MicroSystem
K200044 · Esthetic Education, LLC · Apr 2020
Rejuvapen NXT
K192138 · Refine USA, LLC · Apr 2020
Exceed Microneedling Device
K180778 · Mt. Derm GmbH · Sep 2018
SkinPen Precision System
DEN160029 · Bellus Medical, LLC · Mar 2018