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Sign in to claim this brandGuangdong Newdermo Biotech Co., Ltd.
US
Last updated May 23, 2026
What Guangdong Newdermo Biotech Co., Ltd. makes
Guangdong Newdermo Biotech Co., Ltd. manufactures blue, red, and infrared phototherapy lamps, including portable units like the kingdo and WONDER FAMILY series, as well as LED light therapy masks such as the LumiLips FAC07NA and models FM-01, FM-02, and FM-03. Their product line also includes the AURA and INIA devices, which appear to be LED-based light therapy solutions.
These devices are classified as Class II under regulatory frameworks, with submissions recorded in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The company operates from the United States, adhering to applicable medical device regulations for phototherapy and LED light therapy products.
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 Guangdong Newdermo Biotech Co., Ltd. manufacture?
Guangdong Newdermo Biotech Co., Ltd. specializes in phototherapy and LED light therapy devices. Their primary products include blue, red, and infrared phototherapy lamps, such as the kingdo and WONDER FAMILY series, which are portable units designed for targeted light therapy. They also produce LED light therapy masks, including the LumiLips FAC07NA and models FM-01, FM-02, FM-03, as well as other LED-based devices like the AURA and INIA. These devices are intended for applications such as skin rejuvenation, wound healing, and pain management.
Where is Guangdong Newdermo Biotech Co., Ltd. based?
The company, Guangdong Newdermo Biotech Co., Ltd., operates from the United States. While the name suggests a Guangdong origin, their regulatory submissions and device listings are filed under a US-based entity, indicating their primary operational and compliance presence is within the US market.
Which regulatory registries list devices manufactured by Guangdong Newdermo Biotech Co., Ltd.?
Devices from Guangdong Newdermo Biotech Co., Ltd. are recorded in the FDA’s 510(k) premarket notification database and the Unique Device Identifier (UDI) system. These registries track submissions for Class II devices, which require evidence of substantial equivalence to a predicate device before commercial distribution in the US. The inclusion in these databases reflects compliance with FDA requirements for device classification and traceability.
How are the devices manufactured by Guangdong Newdermo Biotech Co., Ltd. classified under regulatory frameworks?
The devices produced by Guangdong Newdermo Biotech Co., Ltd., such as their phototherapy lamps and LED light therapy products, are classified as Class II under regulatory frameworks like the FDA’s classification system. Class II devices generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. This classification is determined based on factors like the device’s intended use, potential risks, and the level of regulation needed to mitigate those risks.
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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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 403370499
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| kingdo | FM-02 | FDA UDI | Class II | Active |
| Wonder Family | FM-03 | FDA UDI | Class II | Active |
| Voguenow | FM-02 | FDA UDI | Class II | Active |
| Wonder Family | FM-02 | FDA UDI | Class II | Active |
| Newdermo | FM-01 | FDA UDI | Class II | Active |
| kingdo | FM-02 | FDA UDI | Class II | Active |
| Voguenow | FM-02 | FDA UDI | Class II | Active |
| Aura | FM-02 | FDA UDI | Class II | Active |
| Aura | FM-02 | FDA UDI | Class II | Active |
| Inia | FM-02 | FDA UDI | Class II | Active |
| LED Light Therapy Masks (LumiLips FAC07NA) | K260202 | FDA 510(k) | Class II | Active |
| LED light therapy mask (FM-01, FM-02, FM-03) | K223544 | 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.
- Guangdong Newdermo Biotech Co., Ltd Guangzhou Guangdong · CN FEI 3013178978