# Shanghai Omni Laser Skinology Co., Ltd.

- Location (FDA's records): Shanghai, CN
- FDA decisions: 3 (2023–2023): 3 510(k) clearances
- Product codes: GEX (2), ONF (1)
- 510(k) review time since 2016: median 189 days, against 87 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 6 (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)
- Xuzhou Kernel Medical Equipment Co., Ltd.: 1 (https://510kreport.com/company/xuzhou-kernel-medical-equipment)
- Raja Trading Company, Inc.: 1 (https://510kreport.com/company/raja-trading)
- Shandong Huamei Technology Co., Ltd.: 1 (https://510kreport.com/company/shandong-huamei-technology)
- Zhengzhou Bestview ST Co., Ltd.: 1 (https://510kreport.com/company/zhengzhou-bestview-st)
- Alma Lasers, Inc.: 1 (https://510kreport.com/company/alma-lasers)

## Recent decisions
- K230342: Phototherapy System  (OL-PDT950) (Aug 16, 2023)
- K223778: Diode Laser Hair Removal System (RD-SLD600) (Mar 31, 2023)
- K220214: Painless IPL System - KDT750 (Feb 18, 2023)

Source page: https://510kreport.com/company/shanghai-omni-laser-skinology