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Iridex Wireless Footswitch

FDA 510(k)

Class II (US FDA 510(k))

510(k) K062074

by Iridex Corp

Identifiers

510(k) Number
K062074 FDA 510(k)
FDA Product Code
HQF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.4390 FDA 510(k)
Regulation Number
886.4390 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Iridex Wireless Footswitch by Iridex Corp — 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
Iridex Corp

Sources (1)

  • FDA 510(k) K062074 24 fields · synced Jun 18, 2026