# K161286: IPL Therapy Machine

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Adss Development Co., Ltd.
- Decided: Aug 4, 2016 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: 12 generations back to K910422 (1992). 91 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 97 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.

## Most influential descendants
- K192519: Multi-modality workstation (2019), 2 descendants of its own
- K243123: IPL Treatment Device (MDSQMC-01) (2025), 0 descendants of its own
- K232708: Intense pulsed light therapy device (2023), 0 descendants of its own
- K220385: Intense Pulsed Light Equipment (2022), 0 descendants of its own
- K193328: IPL + Diode Laser Machine (2020), 0 descendants of its own

## Indications for use
The VE2000 device is indicated for use in surgical, aesthetic applications in permanent hair reduction, 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/K161286
Methodology: https://510kreport.com/methodology