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FDA 510(k)

LaseMD LEO Laser System

K-Number: K192331 · 2019-11-12

ApplicantLutronic Global
Decision Date2019-11-12
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LaseMD LEO Laser System is a medical device manufactured by Lutronic Global. It received FDA 510(k) clearance on 2019-11-12 under approval number K192331. 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 LaseMD LEO Laser System?

LaseMD LEO Laser System is a medical device that received FDA 510(k) clearance on 2019-11-12. It is manufactured by Lutronic Global. The 510(k) number is K192331.

When was LaseMD LEO Laser System approved by the FDA?

LaseMD LEO Laser System received FDA 510(k) clearance on 2019-11-12, under approval number K192331.

What company makes LaseMD LEO Laser System?

LaseMD LEO Laser System is manufactured by Lutronic Global.

What is the FDA product code for LaseMD LEO Laser System?

The FDA product code for LaseMD LEO 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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