Cleared Traditional

K243143 - E-PEN (E-PEN)

K243143 is an FDA 510(k) clearance for E-PEN (E-PEN), manufactured by Bomtech Electronics 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 189-day FDA review.

K243143 · Bomtech Electronics Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2025
Decision
189d
Days
Class 2
Risk

K243143 is an FDA 510(k) clearance for the E-PEN (E-PEN). Classified as Powered Microneedle Device (product code QAI), Class II - Special Controls.

Submitted by Bomtech Electronics Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on April 7, 2025 after a review of 189 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 Bomtech Electronics Co., Ltd. devices

FDA 510(k) Submission Details - K243143

510(k) Number K243143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2024
Decision Date April 07, 2025
Days to Decision 189 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
74d slower than avg
Panel avg: 115d · This submission: 189d
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

Corazon
Seo Juntaek

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
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