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FDA 510(k)

TRIMEDYNE HOLMIUM LASER SYSTEMS

K-Number: K041660 · 2004-09-08

ApplicantTrimedyne, Inc.
Decision Date2004-09-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

TRIMEDYNE HOLMIUM LASER SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Trimedyne, Inc.. It received FDA 510(k) clearance on 2004-09-08 under 510(k) number K041660. 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 TRIMEDYNE HOLMIUM LASER SYSTEMS?

TRIMEDYNE HOLMIUM LASER SYSTEMS is a medical device that received FDA 510(k) clearance on 2004-09-08. The listed applicant is Trimedyne, Inc.. The 510(k) number is K041660.

When did TRIMEDYNE HOLMIUM LASER SYSTEMS receive FDA 510(k) clearance?

TRIMEDYNE HOLMIUM LASER SYSTEMS received FDA 510(k) clearance on 2004-09-08, under 510(k) number K041660.

Who is the listed applicant for TRIMEDYNE HOLMIUM LASER SYSTEMS?

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 TRIMEDYNE HOLMIUM LASER SYSTEMS?

The FDA product code for TRIMEDYNE HOLMIUM LASER SYSTEMS is GEX. This falls under the Gastroenterology category.

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Other records listing Trimedyne, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K053457VAPORMAX IIK050412VAPORMAXK043012OMNIPULSE MINI, MODEL 2120K022655TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATHK013974RMNIPULSE HOLMIUM LASER SYSTEM/1210; MAX/1210-VHP; JR. 1230-30; N/A 1500-AK002308OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A

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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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