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2 Face / Face Evolution

FDA 510(k)

Class II (US FDA 510(k))

510(k) K171821

by Heat IN A Click

Identifiers

510(k) Number
K171821 FDA 510(k)
FDA Product Code
NFO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5890 FDA 510(k)
Regulation Number
882.5890 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

2 Face / Face Evolution by Heat IN A Click — 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
Heat IN A Click

Sources (1)

  • FDA 510(k) K171821 24 fields · synced Jun 18, 2026