Shanghai Sigma High-Tech Co., Ltd.
Registered establishment in Shanghai, China. 1 device type, 1 clearance.
Shanghai Sigma High-Tech Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Light, Ultraviolet, Dermatological. Its earliest product listing with the FDA dates from 2025.
1device type
1510(k) clearance
Registration
| Registered name | SHANGHAI SIGMA HIGH-TECH CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3023306694 |
| FEI number | 3023306694 |
| Establishment type | Manufacturer |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | The West Wing 1st FL, Building No.7&The East Wing 11th FL, Building No.8, No.388 Shuanglian Road, Xujing Town |
| Postal code | 201702 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Light, Ultraviolet, Dermatological | Class 2 | UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD);, UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) | 2025 | 8 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K242908 | 2024-12-19 | FTC | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1992 |
|---|---|
| Employees | 51-200 |
| Main products | Light therapy equipment, 308nm excimer light therapy, UV phototherapy cabinets, LED light therapy |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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