Avedro, A Glaukos Company

FDA Device Registration & Listing · Burlington, MA, US · Registration 3007851054

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007851054
FEI Number
3007851054
Entity Name
Avedro, A Glaukos Company
City/State/Country
Burlington, MA, US
Establishment Address
30 North Avenue, Burlington, MA 01803, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
Avedro, a Glaukos Company (Owner Number: 10032768)
Owner / Operator Contact Address
30 North Avenue, Burlington, MA 01803, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

KXL System Mosaic Oxygen Delivery System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HQF Laser, Ophthalmic Ophthalmic Class 2 886.4390 2025-03-03
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) Ophthalmic Class 1 886.4750 2025-04-02

Official Correspondent

Kelli Pennie

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Avedro, a Glaukos Company
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K834060 F. & F. Koenigkramer RELIANCE OPHTHALMIC SLIT LAMP R-083 1984-02-04

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007851054. Last updated year: 2026. Please use registration number 3007851054 when referencing this establishment in official correspondence.
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