FDA-Device2020-05-06Class II
MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue.
Boston Scientific Corporation
Hazard
To reinforce existing instructions within the Directions for Use (DFU) and provide further guidance which will be added to the DFU that may reduce the likelihood of metal cap and fiber tip break temperature related complaints.
Sold states
Worldwide distribution - US Nationwide and Global distribution.
Affected count
146,633
Manufactured in
300 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
MoXy Laser Fiber, Material Number 0010-2400 - Product Usage: The fiber can be used for the surgical incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1798-2020Don't want to check this manually?
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