FDA 510(k)

Alma Q

K-Number: K170850 · 2017-06-15

Decision Date2017-06-15

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Alma Q is a medical device manufactured by Alma Lasers , Ltd.. It received FDA 510(k) clearance on 2017-06-15 under approval number K170850. 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 Q?

Alma Q is a medical device that received FDA 510(k) clearance on 2017-06-15. It is manufactured by Alma Lasers , Ltd.. The 510(k) number is K170850.

When was Alma Q approved by the FDA?

Alma Q received FDA 510(k) clearance on 2017-06-15, under approval number K170850.

What company makes Alma Q?

Alma Q is manufactured by Alma Lasers , Ltd..

What is the FDA product code for Alma Q?

The FDA product code for Alma Q is GEX. This falls under the Gastroenterology category.

Other Devices by Alma Lasers , Ltd.

K203441The Alma Hybrid Laser System K212073Alma Diode Tabletop Laser

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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.