Laser Loupes

  • Model / Serial
    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.
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution--USA (nationwide) and the countries of Canada and EU.
  • Product Description
    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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Kerr Corporation, 3225 Deming Way, Middleton WI 53562
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

2 devices with a similar name

Learn more about the data here

  • Model / Serial
  • Product Description
    Dental products - others
  • Manufacturer
  • Model / Serial
    Model Catalog: N/A (Lot serial: ALL LOTS)
  • Product Description
    LASER LOUPES
  • Manufacturer