FDA 510(k)

Laser Thermal Therapy Kit

K-Number: K230460 · 2023-05-22

Decision Date2023-05-22

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Laser Thermal Therapy Kit is a medical device manufactured by Elesta S.P.A. It received FDA 510(k) clearance on 2023-05-22 under approval number K230460. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Laser Thermal Therapy Kit?

Laser Thermal Therapy Kit is a medical device that received FDA 510(k) clearance on 2023-05-22. It is manufactured by Elesta S.P.A. The 510(k) number is K230460.

When was Laser Thermal Therapy Kit approved by the FDA?

Laser Thermal Therapy Kit received FDA 510(k) clearance on 2023-05-22, under approval number K230460.

What company makes Laser Thermal Therapy Kit?

Laser Thermal Therapy Kit is manufactured by Elesta S.P.A.

What is the FDA product code for Laser Thermal Therapy Kit?

The FDA product code for Laser Thermal Therapy Kit is GEX. This falls under the Gastroenterology category.

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Other Devices by Elesta S.P.A

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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.