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FDA 510(k)

NIDEK MULTICOLOR LASER PHOTOCOAGULATOR

K-Number: K110228 · 2011-02-23

ApplicantNidek Incorporated
Decision Date2011-02-23
Product CodeHQB
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NIDEK MULTICOLOR LASER PHOTOCOAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Nidek Incorporated. It received FDA 510(k) clearance on 2011-02-23 under 510(k) number K110228. 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 LASER PHOTOCOAGULATOR?

NIDEK MULTICOLOR LASER PHOTOCOAGULATOR is a medical device that received FDA 510(k) clearance on 2011-02-23. The listed applicant is Nidek Incorporated. The 510(k) number is K110228.

When did NIDEK MULTICOLOR LASER PHOTOCOAGULATOR receive FDA 510(k) clearance?

NIDEK MULTICOLOR LASER PHOTOCOAGULATOR received FDA 510(k) clearance on 2011-02-23, under 510(k) number K110228.

Who is the listed applicant for NIDEK MULTICOLOR LASER PHOTOCOAGULATOR?

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

What is the FDA product code for NIDEK MULTICOLOR LASER PHOTOCOAGULATOR?

The FDA product code for NIDEK MULTICOLOR LASER PHOTOCOAGULATOR is HQB.

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Related Devices (Code: HQB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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