Millensys
US Last updated 23 May 2026
- Devices
- 1
- Registries
- FDA 510(k)FDA
- FDA recalls
- 0
Catalogue
Vision Tools Ref K090668
FDA establishments
- Millensys New Cairo Al Qahirah · EG FEI 3008177920
What Millensys makes
Millensys manufactures vision tools designed for ophthalmic procedures, including diagnostic and surgical instruments used in eye examinations and treatments.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The company’s products are listed in the FDA’s 510(k) registry.
Frequently asked questions
What types of medical devices does Millensys manufacture?
Millensys specialises in vision tools, which include diagnostic and surgical instruments specifically designed for ophthalmic procedures. These devices are used during eye examinations and treatments to enhance precision and safety.
Where is Millensys based?
Millensys is headquartered in the United States. The company’s location is relevant for regulatory oversight and compliance with US medical device regulations.
How are Millensys’ devices classified by the FDA?
Millensys’ vision tools fall under the FDA’s Class II classification. This classification is assigned based on the level of risk associated with the device, where Class II devices require special controls beyond general controls to ensure safety and effectiveness.
Which regulatory registries list Millensys’ devices?
Millensys’ devices are listed in the FDA’s 510(k) registry. This pathway is used for Class II devices that are substantially equivalent to legally marketed predicate devices, ensuring compliance with US regulatory requirements.
How are Millensys’ devices authorised for market use?
Millensys’ vision tools are authorised through the FDA’s 510(k) premarket notification process. This means each device must demonstrate equivalence to a previously authorised device with similar intended use and technological characteristics.
Information
- Country
- US