# K261204: Intense Pulsed Light Therapy Device

- Pathway: 510(k) (Traditional)
- Applicant: Sanhe LEFIS Electronics Co., Ltd.
- Decided: Jun 12, 2026 after 60 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: 12 generations back to K910422 (1992). 91 ancestors in all.
No later device cites it as a predicate yet.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122995: Intense Pulsed Light (Ipl) Systems, Beijing Kes Biology Technology Co., Ltd. (2013) Summary page 6.

## Indications for use
It is indicated for permanent hair reduction, treatment of pigmented lesions, moderate inflammatory acne vulgaris, ephelides and vascular lesions.

Source page: https://510kreport.com/device/K261204
Methodology: https://510kreport.com/methodology