The Alma Soprano Titanium
K-Number: K222064 · 2022-10-12
ApplicantAlma Lasers, Inc.
Decision Date2022-10-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
The Alma Soprano Titanium is a medical device manufactured by Alma Lasers, Inc.. It received FDA 510(k) clearance on 2022-10-12 under approval number K222064. 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 The Alma Soprano Titanium?
The Alma Soprano Titanium is a medical device that received FDA 510(k) clearance on 2022-10-12. It is manufactured by Alma Lasers, Inc.. The 510(k) number is K222064.
When was The Alma Soprano Titanium approved by the FDA?
The Alma Soprano Titanium received FDA 510(k) clearance on 2022-10-12, under approval number K222064.
What company makes The Alma Soprano Titanium?
The Alma Soprano Titanium is manufactured by Alma Lasers, Inc..
What is the FDA product code for The Alma Soprano Titanium?
The FDA product code for The Alma Soprano Titanium 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.