# FDA 483 - Avedro, Inc. - June 26, 2025

Source: https://www.keypedia.com/records/483/avedro-inc/fdd59650-38e1-4faa-be80-b0093f3e349e

> FDA 483 for Avedro, Inc. on June 26, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Avedro, Inc.
- Inspection Date: 2025-06-26
- Product Type: device
- Office Name: New England District Office
- Summary: 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.

## Related Documents

- [483 - 2025-06-26](https://www.keypedia.com/records/483/avedro-inc/e6423316-9d7a-4cd0-99b8-c6f089440e9c)

## Related Officers

- [investigator](https://www.keypedia.com/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.keypedia.com/companies/avedro-inc/c98e81f7-b37c-4a99-9299-7a14ada28546

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144