483
Avedro, Inc.Avedro, Inc. – FDA 483, Jun 26, 2025
Record Details
An FDA inspection of Avedro, a Glaukos Company, in Burlington, MA, revealed two significant issues related to their KXL System, which incorporates a Class 1 Laser. The firm failed to affix new certification labels in accordance with current guidance and has not submitted required annual reports to the FDA since August 2013, despite changes in company information.
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ID · fdd59650-38e1-4faa-be80-b0093f3e349e
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