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FDA 510(k)

UMECO OPTIMA MULTILINE LASER SYSTEM

K-Number: K000693 · 2000-05-16

ApplicantMedical Laser Solutions, LLC
Decision Date2000-05-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UMECO OPTIMA MULTILINE LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Laser Solutions, LLC. It received FDA 510(k) clearance on 2000-05-16 under 510(k) number K000693. 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 UMECO OPTIMA MULTILINE LASER SYSTEM?

UMECO OPTIMA MULTILINE LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2000-05-16. The listed applicant is Medical Laser Solutions, LLC. The 510(k) number is K000693.

When did UMECO OPTIMA MULTILINE LASER SYSTEM receive FDA 510(k) clearance?

UMECO OPTIMA MULTILINE LASER SYSTEM received FDA 510(k) clearance on 2000-05-16, under 510(k) number K000693.

Who is the listed applicant for UMECO OPTIMA MULTILINE LASER SYSTEM?

The FDA 510(k) record lists Medical Laser Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UMECO OPTIMA MULTILINE LASER SYSTEM?

The FDA product code for UMECO OPTIMA MULTILINE LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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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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