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FDA 510(k)

Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System

K-Number: K182663 · 2018-11-30

ApplicantFinemec Co., Ltd.
Decision Date2018-11-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System is a medical device manufactured by Finemec Co., Ltd.. It received FDA 510(k) clearance on 2018-11-30 under approval number K182663. 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 Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System?

Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System is a medical device that received FDA 510(k) clearance on 2018-11-30. It is manufactured by Finemec Co., Ltd.. The 510(k) number is K182663.

When was Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System approved by the FDA?

Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System received FDA 510(k) clearance on 2018-11-30, under approval number K182663.

What company makes Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System?

Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System is manufactured by Finemec Co., Ltd..

What is the FDA product code for Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System?

The FDA product code for Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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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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