# Shanghai Sigma High-Tech Co., Ltd.

- Location (FDA's records): Shanghai, CN
- FDA decisions: 1 (2024–2024): 1 510(k) clearance
- Product codes: FTC (1)
- Predicates its devices cite: 2 (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
- Shenzhen Honpal Optoelectronic Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-honpal-optoelectronic-technology)
- Xuzhou Yongkang Electronic Science Technology Co., Ltd.: 1 (https://510kreport.com/company/xuzhou-yongkang-electronic-science-technology)

## Recent decisions
- K242908: UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) (Dec 19, 2024)

Source page: https://510kreport.com/company/shanghai-sigma-high-tech