Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Ophthalmic Yag Laser System YC-200

K-Number: K203130 · 2020-12-07

ApplicantNidek Co., Ltd.
Decision Date2020-12-07
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 2020-12-07 under approval number K203130. 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 2020-12-07. It is manufactured by Nidek Co., Ltd.. The 510(k) number is K203130.

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

Ophthalmic Yag Laser System YC-200 received FDA 510(k) clearance on 2020-12-07, under approval number K203130.

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.

Related Clinical Trials

NCT07607496 MacuTherm Performance Study in Patients With iAMD NOT_YET_RECRUITING NCT07101809 Trial of Ureteroscopy vs Steerable Continuous Flow Aspiration Technology RECRUITING NCT07214220 Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation RECRUITING NCT07580560 Aqua Therapeutics Thermal Therapy Vapor Ablation System (ATTTVAS) Abnormal Uterine Bleeding Safety Study COMPLETED NCT06795451 Modulating Spinal Interoceptive Pathways to Evaluate Their Role and Therapeutic Potential in MDD Symptomatic Domains RECRUITING NCT07340671 Facial Papules in Frontal Fibrosing Alopecia (FFA) NOT_YET_RECRUITING

Related PubMed Literature

PMID: 32459382 Safety Assessment of an A-Scan Ultrasonic System for Ophthalmic Use. Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine (2020)

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

View all 12 devices →

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.

↑