The Laser Loupes are custom made-to-order products. There are no general model, catalog, code, lot or serial numbers. Laser Loupes have no expiration date. The affected units were produced and distributed since September 2008.
Worldwide Distribution--USA (nationwide) and the countries of Canada and EU.
Description du dispositif
The brand name of the device is Laser Loupes, a dentalloupe || with laser eye protection. Laser Loupes have been assigned product code 79 FSP and are classified as a Class I Medical Devices. || Laser Loupes are || available with four (4) different filters of different colors. Each colored filter is || associated with specific laser frequency ranges. The device listing number for this product is E160359. || The intended use of this device is to magnify the operatory field and provide laser eye protection.