# K232708: Intense pulsed light therapy device

- Pathway: 510(k) (Traditional)
- Applicant: Hebei Zhemai Technology Co., Ltd.
- Decided: Dec 1, 2023 after 87 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: 14 generations back to K910422 (1992). 93 ancestors in all.
No later device cites it as a predicate yet.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192519: Multi-modality workstation, Beijing Superlaser Technology Co., Ltd. (2019) Summary page 38.

## Indications for use
The Intense pulsed light therapy device is indicated for use in surgical and aesthetic applications in permanent hair removal. 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/K232708
Methodology: https://510kreport.com/methodology