# Hebei Keylaser Sci-Tech Co.,Ltd

- Location (FDA's records): Baoding, CN
- FDA decisions: 3 (2024–2025): 3 510(k) clearances
- Product codes: GEX (3)
- 510(k) review time since 2016: median 88 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
- Shangdong Huamei Technology Co., Ltd.: 1 (https://510kreport.com/company/shangdong-huamei-technology)
- Beijing Adss Development Co., Ltd.: 1 (https://510kreport.com/company/beijing-adss-development)
- Guangzhou Chuang Zao Mei Technology Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-chuang-zao-mei-technology)

## Recent decisions
- K252519: CO2 Laser Therapy System (K106) (Nov 7, 2025)
- K252515: Q-Switched Nd:Yag laser (K690) (Nov 6, 2025)
- K241498: Diode laser Treatment System (K18) (Nov 18, 2024)

Source page: https://510kreport.com/company/hebei-keylaser-sci-tech