# K243472: 1NEED Pro

- Pathway: 510(k) (Traditional)
- Applicant: Campomats S.R.L.
- Decided: Mar 19, 2025 after 131 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: 2 generations back to DEN160029 (2018). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230420: Dr. pen Microneedling System, Guangzhou Ekai Electronic Technology Co., Ltd. (2023) Summary page 5.

## Indications for use
The 1NEED Pro 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 or older.

Source page: https://510kreport.com/device/K243472
Methodology: https://510kreport.com/methodology