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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 the device name listed in this FDA 510(k) record. The listed applicant is Alma Lasers, Inc.. It received FDA 510(k) clearance on 2023-03-01 under 510(k) 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. The listed applicant is Alma Lasers, Inc.. The 510(k) number is K230308.

When did Alma Harmony receive FDA 510(k) clearance?

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

Who is the listed applicant for Alma Harmony?

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

What is the FDA product code for Alma Harmony?

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

Other records listing Alma Lasers, Inc. as applicant

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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Related Devices (Code: GEX)

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

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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