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Medtronic Solan Fiberoptic Corneal Light Probe

FDA 510(k)

Class II (US FDA 510(k))

510(k) K000728

by Medtronic Xomed

Identifiers

510(k) Number
K000728 FDA 510(k)
FDA Product Code
FST FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4580 FDA 510(k)
Regulation Number
878.4580 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Medtronic Solan Fiberoptic Corneal Light Probe by Medtronic Xomed — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Medtronic Xomed

Sources (1)

  • FDA 510(k) K000728 24 fields · synced Jun 18, 2026