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FDA 510(k)

COHERENT DIODE PHOTOCOAGULATOR

K-Number: K903689 · 1990-09-20

ApplicantLumenis, Inc.
Decision Date1990-09-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COHERENT DIODE PHOTOCOAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Inc.. It received FDA 510(k) clearance on 1990-09-20 under 510(k) number K903689. 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 DIODE PHOTOCOAGULATOR?

COHERENT DIODE PHOTOCOAGULATOR is a medical device that received FDA 510(k) clearance on 1990-09-20. The listed applicant is Lumenis, Inc.. The 510(k) number is K903689.

When did COHERENT DIODE PHOTOCOAGULATOR receive FDA 510(k) clearance?

COHERENT DIODE PHOTOCOAGULATOR received FDA 510(k) clearance on 1990-09-20, under 510(k) number K903689.

Who is the listed applicant for COHERENT DIODE PHOTOCOAGULATOR?

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 DIODE PHOTOCOAGULATOR?

The FDA product code for COHERENT DIODE PHOTOCOAGULATOR is GEX. This falls under the Gastroenterology category.

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Other records listing Lumenis, 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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