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FDA 510(k)

Green Laser Photocoagulator GYC-500

K-Number: K152603 · 2016-05-02

ApplicantNidek Co., Ltd.
Decision Date2016-05-02
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Green Laser Photocoagulator GYC-500 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 2016-05-02 under 510(k) number K152603. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Green Laser Photocoagulator GYC-500?

Green Laser Photocoagulator GYC-500 is a medical device that received FDA 510(k) clearance on 2016-05-02. The listed applicant is Nidek Co., Ltd.. The 510(k) number is K152603.

When did Green Laser Photocoagulator GYC-500 receive FDA 510(k) clearance?

Green Laser Photocoagulator GYC-500 received FDA 510(k) clearance on 2016-05-02, under 510(k) number K152603.

Who is the listed applicant for Green Laser Photocoagulator GYC-500?

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 Green Laser Photocoagulator GYC-500?

The FDA product code for Green Laser Photocoagulator GYC-500 is HQF.

Other records listing Nidek Co., Ltd. as applicant

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Related Devices (Code: HQF)

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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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