# K243123: IPL Treatment Device (MDSQMC-01)

- Pathway: 510(k) (Traditional)
- Applicant: Medusa (Guangxi)Medical Devices Co., Ltd.
- Decided: Jul 3, 2025 after 276 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: 21 generations back to K910422 (1992). 332 ancestors in all.
No later device cites it as a predicate yet.
0 of 333 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230816: Intense Pulsed Light Treatment System, Shangdong Huamei Technology Co., Ltd. (2023) Summary page 6.
- K192519: Multi-modality workstation, Beijing Superlaser Technology Co., Ltd. (2019) Summary page 6.
- K193500: Stellar M22 for Intense Pulsed Light (IPL) and Laser System, Lumenis, Ltd. (2020) Summary page 6.

## Indications for use
The IPL Treatment Device (Model: MDSQMC-01) is intended for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions. Mild to moderate inflammatory Acne (Acne vulgaris) 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/K243123
Methodology: https://510kreport.com/methodology