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FDA 510(k)

Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece

K-Number: K170626 · 2017-05-31

ApplicantAlma Lasers, Inc.
Decision Date2017-05-31
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece is a medical device manufactured by Alma Lasers, Inc.. It received FDA 510(k) clearance on 2017-05-31 under approval number K170626. 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 Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece?

Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece is a medical device that received FDA 510(k) clearance on 2017-05-31. It is manufactured by Alma Lasers, Inc.. The 510(k) number is K170626.

When was Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece approved by the FDA?

Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece received FDA 510(k) clearance on 2017-05-31, under approval number K170626.

What company makes Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece?

Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece is manufactured by Alma Lasers, Inc..

What is the FDA product code for Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece?

The FDA product code for Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

PMID: 42208661 A FeAsibility items Checklist for assessing implementation characTeristics of patient reported Outcome measures in Research, Regulation and Routine clinical care (FACTOR3): development and evaluation. Clinical medicine (London, England) (2026) PMID: 41116086 Eye-tracking-based tablet application for enhanced cognitive assessment: a clinical trial for software as a medical device (SaMD). GeroScience (2025) PMID: 40948288 [Research on Application of Medical Device Real-World Evidence in Regulatory Decisions of the United States]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) PMID: 40623156 Legal and regulatory challenges in multi-country data-driven projects developing and validating medical AI systems in the EU. Expert review of medical devices (2025)

Other Devices by Alma Lasers, Inc.

K160075Accent XL K171242Alma LipoFlow System K181298Harmony XL Multi-Application Platform K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules K201520The Alma Opus System, Colibri Applicator and Tips K222064The Alma Soprano Titanium

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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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