FDA 510(k)

Alma Diode Tabletop Laser

K-Number: K212073 · 2022-07-14

Decision Date2022-07-14

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Alma Diode Tabletop Laser is a medical device manufactured by Alma Lasers , Ltd.. It received FDA 510(k) clearance on 2022-07-14 under approval number K212073. 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 Alma Diode Tabletop Laser?

Alma Diode Tabletop Laser is a medical device that received FDA 510(k) clearance on 2022-07-14. It is manufactured by Alma Lasers , Ltd.. The 510(k) number is K212073.

When was Alma Diode Tabletop Laser approved by the FDA?

Alma Diode Tabletop Laser received FDA 510(k) clearance on 2022-07-14, under approval number K212073.

What company makes Alma Diode Tabletop Laser?

Alma Diode Tabletop Laser is manufactured by Alma Lasers , Ltd..

What is the FDA product code for Alma Diode Tabletop Laser?

The FDA product code for Alma Diode Tabletop Laser is GEX. This falls under the Gastroenterology category.

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Other Devices by Alma Lasers , Ltd.

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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.