K243143
- 510(k) number
- K243143
- Device name
- E-PEN (E-PEN)
- Applicant
- Bomtech Electronics Co., Ltd. KR
- Product code
- QAI — Powered Microneedle Device
- Decision date
- 2025-04-07
- Date received
- 2024-09-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243143.pdf
Official FDA record: K243143
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.