Mark

Nidek Technologies manages a full quality assurance system ensuring the conformity of products with the relevant essential requirements of the Council Directive 93/42/EEC concerning medical devices.
Nidek Technologies, has been authorized to put the CE mark by the Notified Body TÜV for the following categories of products:

• Devices and Instruments

• Software

for measurement in Diagnostic Ophthalmology.

FDA 510(k)

Under section 510(k) of the Act, a person who intends to introduce a device into commercial distribution is required to provide reasonable assurance of safety and effectiveness and to submit a premarket notification, or 510(k), to FDA.

A Premarket Notification is Required when:

• a new device is being introduced into the US market for the first time;
• the device is not exempt .

Food and Drug Administration has granted 510 (k) clearance for the following Nidek Technologies devices:

• 510(k) NO K012416: Confoscan Confocal Microscope
• 510(k) NO K023719: MP-1 Microperimeter

Meaning of

CE Marking on a product is a declaration that the product complies with the essential requirements of the applicable legislations.
In addition:

1. CE Marking on a product indicates to governmental officials that the product may be legally placed on the market in their country.

2. CE Marking on a product ensures the free movement of the product within the EU single market.

3. CE Marking on a product permits the traceability and the withdrawal of the products potentially dangerous by the manufacturer and the vigilance authority.