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FDA 510(k)

YELLOW LASER PHOTOCOAGULATOR YLC-500

K-Number: K170302 · 2017-06-23

ApplicantNidek Co., Ltd.
Decision Date2017-06-23
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

YELLOW LASER PHOTOCOAGULATOR YLC-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 2017-06-23 under 510(k) number K170302. 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 YELLOW LASER PHOTOCOAGULATOR YLC-500?

YELLOW LASER PHOTOCOAGULATOR YLC-500 is a medical device that received FDA 510(k) clearance on 2017-06-23. The listed applicant is Nidek Co., Ltd.. The 510(k) number is K170302.

When did YELLOW LASER PHOTOCOAGULATOR YLC-500 receive FDA 510(k) clearance?

YELLOW LASER PHOTOCOAGULATOR YLC-500 received FDA 510(k) clearance on 2017-06-23, under 510(k) number K170302.

Who is the listed applicant for YELLOW LASER PHOTOCOAGULATOR YLC-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 YELLOW LASER PHOTOCOAGULATOR YLC-500?

The FDA product code for YELLOW LASER PHOTOCOAGULATOR YLC-500 is 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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