# K193328: IPL + Diode Laser Machine

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Globalipl Development Co., Ltd.
- Decided: Mar 25, 2020 after 114 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: 16 generations back to K910422 (1992). 150 ancestors in all.
No later device cites it as a predicate yet.
0 of 151 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 8.
- K192516: Diode Laser 808nm, Beijing Superlaser Technology Co., Ltd. (2019). Cleared while this submission was under review Summary page 8.

## Indications for use
The IPL + Diode Laser machine (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical, and aesthetic applications in permanent hair reduction, reduction of benign pigmented lesions and benign vascular lesions，and (inclusive of the handpiece used to deliver diode laser energy) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. 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 regime.

Source page: https://510kreport.com/device/K193328
Methodology: https://510kreport.com/methodology