Cleared Traditional

K230420 - Dr. pen Microneedling System

K230420 is an FDA 510(k) clearance for Dr. pen Microneedling System, manufactured by Guangzhou Ekai Electronic Technology Co., Ltd.. The device is a Class 2 General & Plastic Surgery device with product code QAI cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K230420 · Guangzhou Ekai Electronic Technology Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
176d
Days
Class 2
Risk

K230420 is an FDA 510(k) clearance for the Dr. pen Microneedling System. Classified as Powered Microneedle Device (product code QAI), Class II - Special Controls.

Submitted by Guangzhou Ekai Electronic Technology Co., Ltd. (Guangzhou, CN). The FDA issued a Cleared decision on August 11, 2023 after a review of 176 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 Guangzhou Ekai Electronic Technology Co., Ltd. devices

FDA 510(k) Submission Details - K230420

510(k) Number K230420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2023
Decision Date August 11, 2023
Days to Decision 176 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
61d slower than avg
Panel avg: 115d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QAI Device Classification - Class 2, Special Controls

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

New Risen Enterprise Management Consulting Co.,Ltd
Helen Nan

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 K230420.
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