FDA 510(k)

VenusX

K-Number: K232489 · 2024-04-12

Decision Date2024-04-12

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

VenusX is the device name listed in this FDA 510(k) record. The listed applicant is Linatech, LLC. It received FDA 510(k) clearance on 2024-04-12 under 510(k) number K232489. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VenusX?

VenusX is a medical device that received FDA 510(k) clearance on 2024-04-12. The listed applicant is Linatech, LLC. The 510(k) number is K232489.

When did VenusX receive FDA 510(k) clearance?

VenusX received FDA 510(k) clearance on 2024-04-12, under 510(k) number K232489.

Who is the listed applicant for VenusX?

The FDA 510(k) record lists Linatech, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VenusX?

The FDA product code for VenusX is IYE.

Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.