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US
Last updated May 23, 2026
What Zonnsmart Science & Technology Co., Ltd makes
Zonnsmart Science & Technology Co., Ltd manufactures red and infrared light phototherapy units, designed for therapeutic applications using specific wavelength light. These devices are branded under the ZONN name and are intended for controlled exposure to promote healing or other clinical effects.
The company’s phototherapy units fall under Class II regulatory classification in the US, with devices listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable regulatory requirements for medical devices in that jurisdiction.
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 Zonnsmart Science & Technology Co., Ltd manufacture?
Zonnsmart Science & Technology Co., Ltd specializes in red and infrared light phototherapy units. These devices are designed to deliver controlled light exposure for therapeutic purposes, such as promoting healing or addressing specific clinical conditions. The entire product line falls under the ZONN brand.
Where is Zonnsmart Science & Technology Co., Ltd based?
The company is headquartered in the United States. Its operations and manufacturing activities are conducted within this jurisdiction, where it aligns with applicable regulatory standards for medical devices.
Which regulatory registries or databases list Zonnsmart’s devices?
Zonnsmart’s red/infrared light phototherapy units are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class II devices, which include these phototherapy units.
How are Zonnsmart’s devices classified under US regulations?
Zonnsmart’s red/infrared light phototherapy units are classified as Class II devices in the US. This classification is based on their intended use and associated risk level, requiring compliance with specific regulatory controls to ensure safety and effectiveness.
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
- 714639269
Catalogue (14)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Zonn | HL800-MA | FDA UDI | Class II | Active |
| Zonn | HL811 PRO MAX | FDA UDI | Class II | Active |
| Zonn | HL711 PRO MAX | FDA UDI | Class II | Active |
| Zonn | HL880 PRO MAX | FDA UDI | Class II | Active |
| Zonn | HL850 PRO | FDA UDI | Class II | Active |
| Zonn | HL800 | FDA UDI | Class II | Active |
| Zonn | HL700 PRO | FDA UDI | Class II | Active |
| Zonn | HL800 PRO | FDA UDI | Class II | Active |
| Zonn | HL700 PRO MAX | FDA UDI | Class II | Active |
| Zonn | HL811 PRO | FDA UDI | Class II | Active |
| Zonn | BR01 | FDA UDI | Class II | Active |
| Zonn | HL800-BT | FDA UDI | Class II | Active |
| Zonn | HL850 PRO MAX | FDA UDI | Class II | Active |
| Zonn | HL711 PRO | FDA UDI | Class II | Active |
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