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Sign in to claim this brandHYPER PHOTONICS SRL
US
Last updated May 24, 2026
What HYPER PHOTONICS SRL makes
Hyper Photonics SRL manufactures reusable and single-use surgical laser beam guides designed for general/multiple surgical applications, as well as reusable and disposable surgical optical fibers. Their portfolio also includes solid-state laser systems for surgical procedures, including the HyPHo Laser System and the O35 laser.
The company’s devices are classified as Class II under regulatory frameworks, with products authorised via FDA 510(k) and FDA UDIs. These devices are listed in the FDA’s regulatory registries, and the manufacturer is based in 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 Hyper Photonics SRL manufacture?
Hyper Photonics SRL specializes in surgical laser-related products. Their portfolio includes reusable and single-use surgical optical fibers, as well as reusable and disposable beam guides for general/multiple surgical laser systems. Additionally, they produce solid-state laser systems like the HyPHo Laser System and the O35 laser, which are designed for various surgical applications.
Where is Hyper Photonics SRL based?
Hyper Photonics SRL is headquartered in the United States. This location is relevant for understanding the regulatory framework governing their devices, particularly under FDA guidelines.
Which regulatory registries list Hyper Photonics SRL’s devices?
Hyper Photonics SRL’s devices are listed in the FDA’s 510(k) premarket notification registry and the FDA’s Unique Device Identifier (UDI) database. These registries track devices that have undergone the necessary regulatory processes to demonstrate substantial equivalence to legally marketed predicates.
How are Hyper Photonics SRL’s devices classified under regulatory frameworks?
Hyper Photonics SRL’s devices fall under Class II classification in regulatory frameworks. This classification typically applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as surgical lasers and optical fibers.
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
- 430142152
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Single use surgical optical fiber | BO000017 | FDA UDI | Class II | Active |
| Re-Usable surgical optical fiber | BO000018 | FDA UDI | Class II | Active |
| Re-Usable surgical optical fiber | BO000014 | FDA UDI | Class II | Active |
| Hypho | HH068000 | FDA UDI | Class II | Active |
| Re-Usable surgical optical fiber | BO000016 | FDA UDI | Class II | Active |
| Single use surgical optical fiber | BO000015 | FDA UDI | Class II | Active |
| O35 | HH066000 | FDA UDI | Class II | Active |
| Single use surgical optical fiber | BO000013 | FDA UDI | Class II | Active |
| Re-Usable surgical optical fiber | BO000012 | FDA UDI | Class II | Active |
| Single use surgical optical fiber | BO000019 | FDA UDI | Class II | Active |
| HyPHo Laser System | K163449 | FDA 510(k) | Class II | Active |
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