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FDA 510(k)

Alma Harmony

K-Number: K230308 · 2023-03-01

ApplicantAlma Lasers, Inc.
Decision Date2023-03-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Alma Harmony is a medical device manufactured by Alma Lasers, Inc.. It received FDA 510(k) clearance on 2023-03-01 under approval number K230308. 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 Harmony?

Alma Harmony is a medical device that received FDA 510(k) clearance on 2023-03-01. It is manufactured by Alma Lasers, Inc.. The 510(k) number is K230308.

When was Alma Harmony approved by the FDA?

Alma Harmony received FDA 510(k) clearance on 2023-03-01, under approval number K230308.

What company makes Alma Harmony?

Alma Harmony is manufactured by Alma Lasers, Inc..

What is the FDA product code for Alma Harmony?

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

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Official Source

View on FDA Database →

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

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