# K123435: Ipl Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Sincoheren S&T Development Co, Ltd.
- Decided: Feb 11, 2013 after 96 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: 11 generations back to K910422 (1992). 90 ancestors in all.
No later device cites it as a predicate yet.
0 of 91 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093627: Ipulselight Ipl System, Models HS 300C and HS 650, Shanghai Apolo Medical Technologies Co., Ltd. (2011) Summary page 1.

## Indications for use
The intense pulsed light therapy system is indicated for use in surgical, aesthetic and cosmetic application in the hair removal at a wavelength ranging from 690-1200nm.

Source page: https://510kreport.com/device/K123435
Methodology: https://510kreport.com/methodology