FDA-Device2019-10-30Class III
OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036
Xintec Corp
Hazard
It has been determined that a lot of fiber lasers were programmed incorrectly. As a result, the fibers from this lot will produce an error and will not allow the user to use the laser when it is plugged in.
Sold states
PA and VA
Affected count
45 lasers
Manufactured in
1660 S Loop Rd, Alameda, CA, United States
Products
OptiLITE, Products for Laser Surgery, Model # CGH1080F, 800 micron single-use holmium fiber assembly with flat tip, Lot Number 21144, Sterilized by Sterrad Run 4149, This device is for single-use only, sterile, UDI: 00855430006036
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0162-2020Don't want to check this manually?
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