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FDA 510(k)

NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI

K-Number: K111493 · 2011-07-27

ApplicantNidek Co., Ltd.
Decision Date2011-07-27
Product CodeHQB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI is the device name listed in this FDA 510(k) record. The listed applicant is Nidek Co., Ltd.. It received FDA 510(k) clearance on 2011-07-27 under 510(k) number K111493. The device is classified under product code HQB. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI?

NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI is a medical device that received FDA 510(k) clearance on 2011-07-27. The listed applicant is Nidek Co., Ltd.. The 510(k) number is K111493.

When did NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI receive FDA 510(k) clearance?

NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI received FDA 510(k) clearance on 2011-07-27, under 510(k) number K111493.

Who is the listed applicant for NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI?

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

What is the FDA product code for NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI?

The FDA product code for NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI is HQB.

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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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