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FDA 510(k)

Ophthalmic Yag Laser System YC-200

K-Number: K192045 · 2019-11-15

ApplicantNidek Co., Ltd.
Decision Date2019-11-15
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Ophthalmic Yag Laser System YC-200 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 2019-11-15 under 510(k) number K192045. 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 Ophthalmic Yag Laser System YC-200?

Ophthalmic Yag Laser System YC-200 is a medical device that received FDA 510(k) clearance on 2019-11-15. The listed applicant is Nidek Co., Ltd.. The 510(k) number is K192045.

When did Ophthalmic Yag Laser System YC-200 receive FDA 510(k) clearance?

Ophthalmic Yag Laser System YC-200 received FDA 510(k) clearance on 2019-11-15, under 510(k) number K192045.

Who is the listed applicant for Ophthalmic Yag Laser System YC-200?

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 Ophthalmic Yag Laser System YC-200?

The FDA product code for Ophthalmic Yag Laser System YC-200 is HQF.

Other records listing Nidek Co., Ltd. as applicant

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.

K221320Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX; Scanning Laser Ophthalmoscope Mirante [SLO Model] with Image Filing Software NAVIS-EXK203130Ophthalmic Yag Laser System YC-200K190198Microperimeter MP-3, Microperimeter MP-3 Type SK181345Image Filing Software NAVIS-EXK173980Specular Microscope CEM-530PMA P970053Excimer laser system

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Related Devices (Code: HQF)

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.

K252979Voyager DSLT (430840610)Belkin Vision, Ltd.K251507INTEGRE LIOQuantel MedicalK251772Navilas Laser System 577sl (156691)Od-Os GmbHK243014EyeQ nanoECPEyeq, Inc.K240615Leos Laser and Endoscopy SystemBeaver-Visitec International, Inc.K242397LYNX PhotocoagulatorNorlase Aps

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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