FDA-Device2012-11-28Class II
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 protect
Kerr Corporation
Hazard
The firm initiated the recall for Laser Loupes because the ink used to mark which laser frequency each laser Loupe protects against may wipe off. The loupes work according to specification, but the marking may not permanently adhere to the device.
Sold states
Worldwide Distribution--USA (nationwide) and the countries of Canada and EU.
Affected count
639 units
Manufactured in
3225 Deming Way, N/A, Middleton, WI, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0414-2013Don't want to check this manually?
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