# Sanhe Lefis Electronics Co., Ltd.

- Location (FDA's records): Langfang, CN
- FDA decisions: 4 (2025–2026): 4 510(k) clearances
- Names in FDA's records: Sanhe Lefis Electronics Co., Ltd. (2); Sanhe LEFIS Electronics Co., Ltd. (2)
- Product codes: GEX (3), ONF (1)
- 510(k) review time since 2016: median 122 days, against 90 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 5 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Beijing Lead Beauty S & T Co., Ltd.: 1 (https://510kreport.com/company/beijing-lead-beauty-s-t)
- Ilooda Co,., Ltd.: 1 (https://510kreport.com/company/ilooda)
- Shenzhen Gsd Tech Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-gsd-tech)
- Inmode MD, Ltd.: 1 (https://510kreport.com/company/inmode-md)
- Beijing Kes Biology Technology Co., Ltd.: 1 (https://510kreport.com/company/beijing-kes-biology-technology)

## Recent decisions
- K261562: Diode Laser Therapy System (Sep 10, 2026)
- K261204: Intense Pulsed Light Therapy Device (Jun 12, 2026)
- K250998: CO2 Laser Therapy System (Model: LFS-D9U) (Dec 19, 2025)
- K252319: Q-Switched Nd: YAG Laser machine (LFS-C13U) (Oct 20, 2025)

Source page: https://510kreport.com/company/sanhe-lefis-electronics