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Venus Versa PRO System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K232192

by Venus Concept Inc.

Identifiers

510(k) Number
K232192 FDA 510(k)
FDA Product Code
ONF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Venus Versa PRO System by Venus Concept Inc. — 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
Venus Concept Inc.
FDA Applicant
Venus Concept, Inc.

Sources (1)

  • FDA 510(k) K232192 24 fields · synced Jun 18, 2026