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FDA 510(k)

OPTILASE ND:YAG MODELS 1000/4000 SURG LASER SYSTEM

K-Number: K922497 · 1994-03-01

ApplicantTrimedyne, Inc.
Decision Date1994-03-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OPTILASE ND:YAG MODELS 1000/4000 SURG LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Trimedyne, Inc.. It received FDA 510(k) clearance on 1994-03-01 under 510(k) number K922497. 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 ND:YAG MODELS 1000/4000 SURG LASER SYSTEM?

OPTILASE ND:YAG MODELS 1000/4000 SURG LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1994-03-01. The listed applicant is Trimedyne, Inc.. The 510(k) number is K922497.

When did OPTILASE ND:YAG MODELS 1000/4000 SURG LASER SYSTEM receive FDA 510(k) clearance?

OPTILASE ND:YAG MODELS 1000/4000 SURG LASER SYSTEM received FDA 510(k) clearance on 1994-03-01, under 510(k) number K922497.

Who is the listed applicant for OPTILASE ND:YAG MODELS 1000/4000 SURG LASER SYSTEM?

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 ND:YAG MODELS 1000/4000 SURG LASER SYSTEM?

The FDA product code for OPTILASE ND:YAG MODELS 1000/4000 SURG LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Trimedyne, Inc. as applicant

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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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