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Sign in to claim this brandShenzhen Saidi Light Therapy Technology Co., Ltd.
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Last updated May 25, 2026
What Shenzhen Saidi Light Therapy Technology Co., Ltd. makes
The company manufactures LED-based red light phototherapy units, including handheld devices and facial masks designed for localized light therapy applications. Products include portable red light units and customizable masks with adjustable coverage areas, targeting skin and tissue treatment.
These devices are classified as Class II under regulatory frameworks, with authorizations granted through FDA 510(k) and UDI listings. The company operates from the United States, adhering to applicable medical device regulations for phototherapy equipment.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Shenzhen Saidi Light Therapy Technology Co., Ltd. manufacture?
Shenzhen Saidi Light Therapy Technology Co., Ltd. specializes in LED-based red light phototherapy units. These devices are designed for localized light therapy and include handheld units as well as facial masks (such as the FM60X, FM80-W, and FM100X series). The products are intended for applications like skin and tissue treatment, leveraging red/infrared light technology.
Where is Shenzhen Saidi Light Therapy Technology Co., Ltd. based?
The company operates from the United States, where it develops and manufactures its red light phototherapy devices. This location ensures compliance with U.S. regulatory requirements for medical devices, including those classified under the FDA’s framework.
Which regulatory registries or databases list Shenzhen Saidi Light Therapy Technology Co., Ltd.’s devices?
The company’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries confirm the devices’ classification and compliance with U.S. regulatory standards, though individual device authorizations depend on FDA review processes.
How are Shenzhen Saidi Light Therapy Technology Co., Ltd.’s devices classified under regulatory frameworks?
The company’s red light phototherapy units fall under Class II classification in regulatory systems like the FDA. This classification typically applies to devices with moderate risk, requiring special controls beyond general controls to ensure safety and effectiveness. The classification is determined by factors like the device’s intended use and potential health impact.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 616675210
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Led Red Light | BV302U | FDA UDI | Class II | Active |
| Led Red Light | KALA PRO | FDA UDI | Class II | Active |
| Led Red Light | KALA Elite | FDA UDI | Class II | Active |
| Led Red Light | BV302 | FDA UDI | Class II | Active |
| Led Red Light | BV301 | FDA UDI | Class II | Active |
| Led Red Light | BV901 | FDA UDI | Class II | Active |
| LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) | K253400 | FDA 510(k) | Class II | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Shenzhen Saidi Light Therapy Technology Co., Ltd. Shenzhen Guangdong · CN FEI 3021386683