# K230490: PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan Hunter Electronic Technology Co., Ltd.
- Decided: Oct 27, 2023 after 246 days
- Product code: OLP (Over-The-Counter Powered Light Based Laser For Acne)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K943450 (1995). 149 ancestors in all.
No later device cites it as a predicate yet.
0 of 150 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162098: LED Phototherapy Device, Li-Tek Electronic Technology Corporation (2017) Summary page 5.

## Indications for use
The pmd clean acne is intended for over-the-counter use to treat mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K230490
Methodology: https://510kreport.com/methodology