# K250206: Diode laser system (Night Universe; Predator)

- Pathway: 510(k) (Traditional)
- Applicant: Ivylaser (Beijing) Technology Co.,Ltd
- Decided: Apr 24, 2025 after 90 days
- Product code: GEX (Powered Laser Surgical Instrument)
- 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: 25 generations back to K943450 (1995). 567 ancestors in all.
No later device cites it as a predicate yet.
0 of 568 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222064: The Alma Soprano Titanium, Alma Lasers, Inc. (2022) Summary page 5.
- K123483: Diode Laser, Beijing Syntech Laser CO., LTD. (2013) Summary page 5.

## Indications for use
Diode laser system is used for hair removal, HR mode is for professional hair removal, and FHR is for rapid hair removal. The indications for use for the 810nm Diode Laser Module include: The HR mode and FHR mode are intended for hair removal and permanent hair reduction. Use on all skin types (Fitzpatrick 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/K250206
Methodology: https://510kreport.com/methodology