E-PEN (E-PEN)— 510(k) K243143

Substantially Equivalent

Bomtech Electronics Co., Ltd.

FDA 510(k) clearance K243143 for E-PEN (E-PEN), Substantially Equivalent on 2025-04-07. Applicant: Bomtech Electronics Co., Ltd.. Device class: 2.

Clearance details

Applicant: Bomtech Electronics Co., Ltd.
Product code: Code QAI
Device class: Class 2
Regulation: 21 CFR 878.4430
Advisory panel: General, Plastic Surgery
Date received: 2024-09-30
Decision date: 2025-04-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.