Cleared Traditional

K243143 - E-PEN (E-PEN) (FDA 510(k) Clearance)

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

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

Submission Details

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
75d slower than avg
Panel avg: 114d · This submission: 189d
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

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 24
Devices cleared under the same product code (QAI) and FDA review panel - the closest regulatory comparables to K243143.
SkinStylus SteriLock MicroSystem (MP1209SL)
K253002 · Esthetic Medical, Inc. · Feb 2026
ellacor System with Micro-Coring Technology
K252752 · Cytrellis Biosystems, Inc. · Oct 2025
SER Pen Carain MicroSystem (MP1209SP)
K253153 · Su-Ko Technologies, LLC · Oct 2025
PRO Pen Microneedling System (6883)
K243800 · Dermalogica, LLC · Aug 2025
1NEED Pro
K243472 · Campomats S.R.L. · Mar 2025
XCELLARISPRO TWIST microneedling device
K241790 · Dermaroller GmbH · Mar 2025