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FDA 510(k)

OPTILASE (TM) MODEL 900 ARGON

K-Number: K903838 · 1991-03-05

ApplicantTrimedyne, Inc.
Decision Date1991-03-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPTILASE (TM) MODEL 900 ARGON is the device name listed in this FDA 510(k) record. The listed applicant is Trimedyne, Inc.. It received FDA 510(k) clearance on 1991-03-05 under 510(k) number K903838. 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 OPTILASE (TM) MODEL 900 ARGON?

OPTILASE (TM) MODEL 900 ARGON is a medical device that received FDA 510(k) clearance on 1991-03-05. The listed applicant is Trimedyne, Inc.. The 510(k) number is K903838.

When did OPTILASE (TM) MODEL 900 ARGON receive FDA 510(k) clearance?

OPTILASE (TM) MODEL 900 ARGON received FDA 510(k) clearance on 1991-03-05, under 510(k) number K903838.

Who is the listed applicant for OPTILASE (TM) MODEL 900 ARGON?

The FDA 510(k) record lists Trimedyne, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPTILASE (TM) MODEL 900 ARGON?

The FDA product code for OPTILASE (TM) MODEL 900 ARGON is GEX. This falls under the Gastroenterology category.

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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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