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FDA 510(k)

The Alma Hybrid Laser System

K-Number: K251230 · 2025-05-21

ApplicantAlma Lasers, Inc.
Decision Date2025-05-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

The Alma Hybrid Laser System is a medical device manufactured by Alma Lasers, Inc.. It received FDA 510(k) clearance on 2025-05-21 under approval number K251230. 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 Hybrid Laser System?

The Alma Hybrid Laser System is a medical device that received FDA 510(k) clearance on 2025-05-21. It is manufactured by Alma Lasers, Inc.. The 510(k) number is K251230.

When was The Alma Hybrid Laser System approved by the FDA?

The Alma Hybrid Laser System received FDA 510(k) clearance on 2025-05-21, under approval number K251230.

What company makes The Alma Hybrid Laser System?

The Alma Hybrid Laser System is manufactured by Alma Lasers, Inc..

What is the FDA product code for The Alma Hybrid Laser System?

The FDA product code for The Alma Hybrid Laser System is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

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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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