# Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd

- Location (FDA's records): Shanghai, CN
- FDA decisions: 6 (2016–2024): 6 510(k) clearances
- Product codes: GEX (4), PKT (1), NVK (1)
- 510(k) review time since 2016: median 103 days, against 90 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 9 (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
- Wuhan Pioon Technology Co., Ltd.: 2 (https://510kreport.com/company/wuhan-pioon-technology)
- Cynosure, Inc.: 1 (https://510kreport.com/company/cynosure)
- Wuhan Lotuxs Technology Co., Ltd.: 1 (https://510kreport.com/company/wuhan-lotuxs-technology)
- Sandstone Medical Technologies, LLC: 1 (https://510kreport.com/company/sandstone-medical-technologies)
- Guilin Woodpecker Medical Instrument Co., Ltd.: 1 (https://510kreport.com/company/guilin-woodpecker-medical-instrument)
- Fotona D.O.O.: 1 (https://510kreport.com/company/fotona-doo)
- Cynosure, Inc. Dba Ellman: 1 (https://510kreport.com/company/cynosure-dba-ellman)
- Triangel Rsd Limited: 1 (https://510kreport.com/company/triangel-rsd)

## Recent decisions
- K243037: Diode Laser System model Dawn-S (Dec 26, 2024)
- K232885: Dawn Diode Laser System (Feb 28, 2024)
- K222265: Diosculpt (Sep 23, 2022)
- K183122: 810nm Diode Laser System (Aug 25, 2019)
- K163655: Sparkling (Mar 17, 2017)
- K161356: Matrix LS-40 CO2 Laser System (Sep 9, 2016)

Source page: https://510kreport.com/company/shanghai-wonderful-opto-electrics-tech