# Sanhe Meditech Co., Ltd.

- Location (FDA's records): Sanhe, CN
- FDA decisions: 3 (2025–2026): 3 510(k) clearances
- Product codes: GEX (3)
- 510(k) review time since 2016: median 59 days, against 90 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 3 (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 Superlaser Technology Co., Ltd.: 1 (https://510kreport.com/company/beijing-superlaser-technology)
- Shangdong Huamei Technology Co., Ltd.: 1 (https://510kreport.com/company/shangdong-huamei-technology)
- Zhengzhou Bestview ST Co., Ltd.: 1 (https://510kreport.com/company/zhengzhou-bestview-st)

## Recent decisions
- K260375: Nd: YAG Laser Therapy Systems (Mar 31, 2026)
- K260257: CO2 Laser System (Mar 28, 2026)
- K252427: Diode Laser Hair Removal Machine (GLD01) (Oct 31, 2025)

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