# K230816: Intense Pulsed Light Treatment System

- Pathway: 510(k) (Special)
- Applicant: Shangdong Huamei Technology Co., Ltd.
- Decided: Apr 21, 2023 after 28 days
- Product code: ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect)
- 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: 13 generations back to K910422 (1992). 92 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192521: Intense Pulsed Light Treatment System, Shangdong Huamei Technology Co., Ltd. (2019) Summary page 5.

## Most influential descendants
- K243123: IPL Treatment Device (MDSQMC-01) (2025), 0 descendants of its own

## Indications for use
The Intense Pulsed Light Treatment System (Model: HM-IPL-BB) are indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

Source page: https://510kreport.com/device/K230816
Methodology: https://510kreport.com/methodology