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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 a medical device manufactured by Nidek Co., Ltd.. It received FDA 510(k) clearance on 2019-11-15 under approval 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. It is manufactured by Nidek Co., Ltd.. The 510(k) number is K192045.

When was Ophthalmic Yag Laser System YC-200 approved by the FDA?

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

What company makes Ophthalmic Yag Laser System YC-200?

Ophthalmic Yag Laser System YC-200 is manufactured by Nidek Co., Ltd..

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.

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Nidek Co., Ltd.

K152729MICROPERIMETER MP-3 K152603Green Laser Photocoagulator GYC-500 K151706Specular Microscope CEM- 530 K170302YELLOW LASER PHOTOCOAGULATOR YLC-500 K163564SLIT LAMP SL-2000 K181345Image Filing Software NAVIS-EX

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Related Devices (Code: HQF)

K153769R:GEN Laser SystemLutronic Corporation K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation K152603Green Laser Photocoagulator GYC-500Nidek Co., Ltd. K171488PSLT for PASCAL StreamlineTopcon Medical Laser Systems, Inc. K170067EasyretQuantel Medical K170302YELLOW LASER PHOTOCOAGULATOR YLC-500Nidek Co., Ltd.

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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