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Sign in to claim this brandCOSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL
US
Last updated May 23, 2026
What COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL makes
The company manufactures ophthalmic examination devices, including slit lamps for detailed eye inspections, manual tonometers for measuring intraocular pressure, and fundus cameras for capturing retinal images. Notable products include the S4 OPTIK series and the LUMENIS models, designed for clinical use in eye care settings.
These devices fall under Class II regulatory classification and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates within the United States, adhering to applicable medical device regulations.
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 COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL manufacture?
COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL specializes in ophthalmic examination devices. Their primary products include slit lamps, which are used for detailed eye inspections, manual tonometers for measuring intraocular pressure, and fundus cameras for capturing high-resolution images of the retina. These tools are essential for diagnosing and monitoring eye conditions in clinical settings.
Where is COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL based?
The company is based in the United States. This location means their devices are subject to U.S. regulatory requirements, including compliance with the FDA’s medical device regulations.
Which regulatory registries list the devices manufactured by COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL?
The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify their products, ensuring traceability and compliance with U.S. medical device regulations.
How are the devices produced by COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL classified under medical device regulations?
The devices manufactured by COSTRUZIONI STRUMENTI OFTALMICI C.S.O. SRL fall under Class II regulatory classification. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure their safety and effectiveness, such as additional testing or labeling requirements.
What is the significance of the S4 OPTIK and LUMENIS models produced by the company?
The S4 OPTIK and LUMENIS models are notable examples of the company’s product lineup, specifically designed for ophthalmic examinations. The S4 OPTIK series appears frequently in their offerings and likely represents their core slit lamp or related diagnostic devices, while the LUMENIS models may include specialized equipment like fundus cameras or other advanced imaging tools. These products are tailored for clinical use in eye care.
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
- 432448470
Catalogue (39)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| S4 Optik | SL 9800 3X | FDA UDI | Class II | Active |
| Iridex | SL 9900 5X | FDA UDI | Class II | Active |
| S4 Optik | SL 9900 2X LED | FDA UDI | Class II | Active |
| Lumenis | SL 9900 5X digital | FDA UDI | Class II | Active |
| S4 Optik | SL 9800 5X LED | FDA UDI | Class II | Active |
| S4 Optik | SL 9800 ZOOM LED | FDA UDI | Class II | Active |
| S4 Optik | SL 990 5X ELITE | FDA UDI | Class II | Active |
| S4 Optik | TONOMETER A900 | FDA UDI | Class II | Active |
| Lumenis | SL 990 5X LUMENIS | FDA UDI | Class II | Active |
| S4 Optik | SL 9800 5X digital | FDA UDI | Class II | Active |
| S4 Optik | TONOMETER F900 | FDA UDI | Class II | Active |
| S4 Optik | SL 990 2X LED | FDA UDI | Class II | Active |
| S4 Optik | SL 9900 3X LED digital | FDA UDI | Class II | Active |
| Iridex | SL 9900 3X | FDA UDI | Class II | Active |
| S4 Optik | SL 9800 3X LED + FILTER | FDA UDI | Class II | Active |
| S4 Optik | COBRA | FDA UDI | Class II | Active |
| Lumenis | SL 990 5X/Z LUMENIS | FDA UDI | Class II | Active |
| S4 Optik | SL 9900 5X ELITE | FDA UDI | Class II | Active |
| S4 Optik | SL 9800 2X | FDA UDI | Class II | Active |
| S4 Optik | SL 9900 5X LED | FDA UDI | Class II | Active |
| S4 Optik | SL 9800 2X LED | FDA UDI | Class II | Active |
| S4 Optik | SL 9800 zoom | FDA UDI | Class II | Active |
| S4 Optik | SL 990 5X LED digital | FDA UDI | Class II | Active |
| S4 Optik | SL 990 5X | FDA UDI | Class II | Active |
| S4 Optik | SL 9800 5X LED | FDA UDI | Class II | Active |
| Lumenis | SL 9800 5X | FDA UDI | Class II | Active |
| S4 Optik | SL 9900 5X LED | FDA UDI | Class II | Active |
| S4 Optik | SL 9900 3X LED | FDA UDI | Class II | Active |
| S4 Optik | SL 9900 3X | FDA UDI | Class II | Active |
| S4 Optik | SL 9900 3X DIGITAL | FDA UDI | Class II | Active |
| Iridex | SL 9800 5X | FDA UDI | Class II | Active |
| Lumenis | SL 9900 5X | FDA UDI | Class II | Active |
| Iridex | SL 980 5X | FDA UDI | Class II | Active |
| S4 Optik | SL 9800 5X LED DIGITAL | FDA UDI | Class II | Active |
| S4 Optik | SL 9800 3X LED | FDA UDI | Class II | Active |
| Alcon | SLIT LAMP SL 1000 | FDA UDI | Class II | Active |
| Lumenis | SL 990 3X LUMENIS | FDA UDI | Class II | Active |
| Iridex | SL 9800 3X | FDA UDI | Class II | Active |
| S4 Optik | SL 990 25X LED | FDA UDI | Class II | Active |
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