# K230420: Dr. pen Microneedling System

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Ekai Electronic Technology Co., Ltd.
- Decided: Aug 11, 2023 after 176 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.
3 later devices descend from it; 3 cite it directly.
0 of 5 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 4.

## Most influential descendants
- K252591: Automatic Micro Needle System (CODE-X) (2026), 0 descendants of its own
- K243800: PRO Pen Microneedling System (6883) (2025), 0 descendants of its own
- K243472: 1NEED Pro (2025), 0 descendants of its own

## Indications for use
The Dr.pen Microneedling System 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/K230420
Methodology: https://510kreport.com/methodology