# K192519: Multi-modality workstation

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Superlaser Technology Co., Ltd.
- Decided: Nov 27, 2019 after 75 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.
2 later devices descend from it; 2 cite it directly.
0 of 95 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.

## Most influential descendants
- K243123: IPL Treatment Device (MDSQMC-01) (2025), 0 descendants of its own
- K232708: Intense pulsed light therapy device (2023), 0 descendants of its own

## Indications for use
The Multi-modality workstation (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical and aesthetic applications in permanent hair removal, 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/K192519
Methodology: https://510kreport.com/methodology