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FDA 510(k)

MODIFIED MODEL 1000 OPTILASE(TM) ND:YAG LASER

K-Number: K890279 · 1989-02-07

ApplicantTrimedyne, Inc.
Decision Date1989-02-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFIED MODEL 1000 OPTILASE(TM) ND:YAG LASER is the device name listed in this FDA 510(k) record. The listed applicant is Trimedyne, Inc.. It received FDA 510(k) clearance on 1989-02-07 under 510(k) number K890279. 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 MODIFIED MODEL 1000 OPTILASE(TM) ND:YAG LASER?

MODIFIED MODEL 1000 OPTILASE(TM) ND:YAG LASER is a medical device that received FDA 510(k) clearance on 1989-02-07. The listed applicant is Trimedyne, Inc.. The 510(k) number is K890279.

When did MODIFIED MODEL 1000 OPTILASE(TM) ND:YAG LASER receive FDA 510(k) clearance?

MODIFIED MODEL 1000 OPTILASE(TM) ND:YAG LASER received FDA 510(k) clearance on 1989-02-07, under 510(k) number K890279.

Who is the listed applicant for MODIFIED MODEL 1000 OPTILASE(TM) ND:YAG LASER?

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 MODIFIED MODEL 1000 OPTILASE(TM) ND:YAG LASER?

The FDA product code for MODIFIED MODEL 1000 OPTILASE(TM) ND:YAG LASER 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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