Alma Harmony
K-Number: K243044 · 2025-04-11
ApplicantAlma Lasers, Inc.
Decision Date2025-04-11
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 2025-04-11 under approval number K243044. 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 2025-04-11. It is manufactured by Alma Lasers, Inc.. The 510(k) number is K243044.
When was Alma Harmony approved by the FDA?
Alma Harmony received FDA 510(k) clearance on 2025-04-11, under approval number K243044.
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.