# K220385: Intense Pulsed Light Equipment

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Globalipl Development Co., Ltd.
- Decided: Aug 12, 2022 after 183 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.
No later device cites it as a predicate yet.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161286: IPL Therapy Machine, Beijing Adss Development Co., Ltd. (2016) Summary page 5.

## Indications for use
The US 500 Intense Pulsed Light Equipment is indicated for use in surgical and aesthetic applications in permanent hair removal. Permanent hair removal 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/K220385
Methodology: https://510kreport.com/methodology