# K243143: E-Pen (E-Pen)

- Pathway: 510(k) (Traditional)
- Applicant: Bomtech Electronics Co., Ltd.
- Decided: Apr 7, 2025 after 189 days
- Product code: QAI (Powered Microneedle Device)
- Device class: 2
- Regulation: 21 CFR 878.4430
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN160029 (2018). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN160029: SkinPen Precision System, Bellus Medical, LLC (2018) Summary page 5.

## Indications for use
The E-PEN is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years and older.

Source page: https://510kreport.com/device/K243143
Methodology: https://510kreport.com/methodology