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FDA 510(k)

The Alma Soprano Titanium

K-Number: K230371 · 2023-02-22

ApplicantAlma Lasers, Inc.
Decision Date2023-02-22
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 2023-02-22 under approval number K230371. 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 2023-02-22. It is manufactured by Alma Lasers, Inc.. The 510(k) number is K230371.

When was The Alma Soprano Titanium approved by the FDA?

The Alma Soprano Titanium received FDA 510(k) clearance on 2023-02-22, under approval number K230371.

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.

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