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Sign in to claim this brandIMI Healing Technologies Inc
US
Last updated May 24, 2026
What IMI Healing Technologies Inc makes
IMI Healing Technologies Inc manufactures phototherapy devices that emit blue, red, and infrared light. Their primary product, the LEP 2000 Photonic Therapy System, is designed for therapeutic applications using controlled light wavelengths. These systems are intended for medical use in wound healing and tissue repair processes. The devices are engineered to deliver targeted photonic energy for clinical treatment purposes.
The company’s phototherapy systems fall under FDA Class II regulatory classification and are listed in the FDA’s Unique Device Identifier (UDI) database. These devices are subject to U.S. regulatory requirements for medical devices, ensuring compliance with safety and performance standards. The manufacturer operates within the United States, adhering to domestic regulatory frameworks for device authorisation.
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 IMI Healing Technologies Inc manufacture?
IMI Healing Technologies Inc specializes in phototherapy devices that emit blue, red, and infrared light. Their primary offering is the LEP 2000 Photonic Therapy System, designed for therapeutic uses such as wound healing and tissue repair. These devices deliver controlled light wavelengths for clinical treatment purposes.
Where is IMI Healing Technologies Inc based?
IMI Healing Technologies Inc is headquartered in the United States. As a U.S.-based manufacturer, their devices are subject to domestic regulatory requirements, including compliance with FDA standards for medical device authorisation.
Which regulatory registries list IMI Healing Technologies Inc’s devices?
IMI Healing Technologies Inc’s devices, including the LEP 2000 Photonic Therapy System, are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class II devices under U.S. regulatory oversight.
How are IMI Healing Technologies Inc’s devices classified under U.S. regulations?
IMI Healing Technologies Inc’s phototherapy devices, such as the LEP 2000 Photonic Therapy System, are classified as Class II under FDA regulations. This classification indicates moderate regulatory controls, including performance standards and post-market surveillance, to ensure safety and effectiveness for their intended medical uses.
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
- 248483948
Catalogue (6)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| LEP 2000 Photonic Therapy System | LEP2000100C | FDA UDI | Class II | Active |
| LEP 2000 Photonic Therapy System | LD100 | FDA UDI | Class II | Active |
| LEP 2000 Photonic Therapy System | LEP2000100A | FDA UDI | Class II | Active |
| LEP 2000 Photonic Therapy System | LEP2000100B | FDA UDI | Class II | Active |
| LEP 2000 Photonic Therapy System | LEP2000100D | FDA UDI | Class II | Active |
| LEP 2000 Photonic Therapy System | 1 | FDA UDI | Class II | Active |
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