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Sign in to claim this brandILUMINAGE LTD
US
Last updated May 30, 2026
What ILUMINAGE LTD makes
Iluminage Ltd manufactures home-use cosmetic red-light phototherapy systems designed for skin rejuvenation and treatment of conditions like acne or photoaging. These devices emit specific wavelengths of red light to target skin concerns, with a focus on non-invasive, at-home therapy solutions.
The company’s portfolio is regulated as Class II medical devices under FDA guidelines and is listed in the FDA’s Unique Device Identification (UDI) system. Iluminage Ltd operates from the United States.
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 Iluminage Ltd manufacture?
Iluminage Ltd specializes in cosmetic red-light phototherapy systems designed for home use. These devices are intended for skin rejuvenation and the treatment of conditions like acne or photoaging. They emit targeted red-light wavelengths to promote skin healing and improvement without invasive procedures.
Where is Iluminage Ltd based, and how does that affect its regulatory oversight?
Iluminage Ltd is based in the United States, which means its devices fall under FDA jurisdiction. Since these products are classified as Class II medical devices, they are subject to FDA regulations, including mandatory listing in the FDA’s Unique Device Identification (UDI) system to ensure traceability and compliance.
Which regulatory registries or databases list Iluminage Ltd’s devices?
Iluminage Ltd’s devices are listed in the FDA’s Unique Device Identification (UDI) system, a mandatory registry for Class II medical devices in the U.S. This system helps track and verify device identification, ensuring transparency and regulatory compliance for authorized products.
How are Iluminage Ltd’s devices classified under medical device regulations?
Iluminage Ltd’s cosmetic red-light phototherapy systems are classified as Class II medical devices by the FDA. This classification indicates moderate regulatory controls, including performance standards and post-market surveillance, to ensure safety and effectiveness while balancing innovation and accessibility for at-home use.
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
- 533309022
Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Me | HU-CO00341 | FDA UDI | Class II | Active |
| Me | HU-FG00691NA | FDA UDI | Class II | Active |
| Iluminage | HU-FG01171VC | FDA UDI | Class II | Active |
| Me | HU-FG00501NA | FDA UDI | Class II | Active |
| Me | HU-FG00691WL | FDA UDI | Class II | Active |
| Iluminage | FG70701US-S | FDA UDI | Class II | Active |
| Me | HU-CO00771 | FDA UDI | Class II | Active |
| Iluminage | HU-FG01171US | FDA UDI | Class II | Active |
| Iluminage | FG70701US-Q | FDA UDI | Class II | Active |
| Me | HU-FG00501US | FDA UDI | Class II | Active |
| Me | HU-CO00721 | FDA UDI | Class II | Active |
| Iluminage | HU-CO00541 | FDA UDI | Class II | Active |
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