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FDA 510(k)

MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300

K-Number: K042785 · 2004-12-14

ApplicantNidek, Inc.
Decision Date2004-12-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300 is the device name listed in this FDA 510(k) record. The listed applicant is Nidek, Inc.. It received FDA 510(k) clearance on 2004-12-14 under 510(k) number K042785. 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 MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300?

MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300 is a medical device that received FDA 510(k) clearance on 2004-12-14. The listed applicant is Nidek, Inc.. The 510(k) number is K042785.

When did MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300 receive FDA 510(k) clearance?

MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300 received FDA 510(k) clearance on 2004-12-14, under 510(k) number K042785.

Who is the listed applicant for MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300?

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

What is the FDA product code for MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300?

The FDA product code for MULTI COLOR LASER PHOTOCOAGULATOR, MODEL MC-300 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.

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