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Sign in to claim this brandFreedom Laser Therapy, Inc.
US
Last updated May 24, 2026
What Freedom Laser Therapy, Inc. makes
Freedom Laser Therapy, Inc. manufactures laser devices designed for hair growth, including handheld and professional-grade systems. These products use laser technology to target hair follicles, aiming to stimulate growth in areas affected by thinning or balding. Examples include portable units like the iRestore and advanced systems such as the ID-500 iRestore Hair Growth System and iRestore Professional 282.
The company’s devices fall under Class II regulatory classification in the US, requiring premarket notification (510(k)) and inclusion in the FDA’s Unique Device Identifier (UDI) database. These products are listed under the FDA’s regulatory pathways for laser-based hair growth systems, ensuring compliance with medical device standards.
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 Freedom Laser Therapy, Inc. manufacture?
Freedom Laser Therapy, Inc. specializes in laser devices primarily designed for hair growth. Their products include handheld units like the iRestore and professional-grade systems such as the ID-500 iRestore Hair Growth System and iRestore Professional 282. These devices use laser technology to target hair follicles, aiming to promote growth in areas experiencing thinning or balding.
Where is Freedom Laser Therapy, Inc. based?
Freedom Laser Therapy, Inc. is based in the United States. The company’s headquarters and operations are located within the country, though specific regional offices or manufacturing sites are not provided in the available data.
Which regulatory registries list Freedom Laser Therapy, Inc.’s devices?
Freedom Laser Therapy, Inc.’s devices are listed under the FDA’s premarket notification (510(k)) pathway and included in the FDA’s Unique Device Identifier (UDI) database. These registries ensure compliance with US medical device regulations for Class II devices, which include their laser-based hair growth systems.
How are Freedom Laser Therapy, Inc.’s devices classified under US regulations?
Freedom Laser Therapy, Inc.’s devices fall under Class II regulatory classification in the US. This classification requires manufacturers to submit a premarket notification (510(k)) to demonstrate substantial equivalence to a legally marketed predicate device and mandates inclusion in the FDA’s UDI database. Class II devices are considered to have an acceptable level of risk that can be managed through general or special controls.
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
- 026237853
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| iRestore | ID-505 | FDA UDI | Class II | Active |
| ID-500 iRestore Hair Growth System | K213094 | FDA 510(k) | Class II | Active |
| iRestore Professional 282 | K183417 | FDA 510(k) | Class II | Active |
| ID-510 iRestore Elite | K222081 | FDA 510(k) | Class II | Active |
| iRestore | K151662 | FDA 510(k) | Class II | Active |
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