FDA 510(k)

COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L

K-Number: K974789 · 1998-03-09

Decision Date1998-03-09

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Inc.. It received FDA 510(k) clearance on 1998-03-09 under 510(k) number K974789. 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 COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L?

COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L is a medical device that received FDA 510(k) clearance on 1998-03-09. The listed applicant is Lumenis, Inc.. The 510(k) number is K974789.

When did COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L receive FDA 510(k) clearance?

COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L received FDA 510(k) clearance on 1998-03-09, under 510(k) number K974789.

Who is the listed applicant for COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L?

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

What is the FDA product code for COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L?

The FDA product code for COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L 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.