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)

Green Laser Photocoagulator GYC-500

K-Number: K152603 · 2016-05-02

ApplicantNidek Co., Ltd.
Decision Date2016-05-02
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Green Laser Photocoagulator GYC-500 is a medical device manufactured by Nidek Co., Ltd.. It received FDA 510(k) clearance on 2016-05-02 under approval number K152603. 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 Green Laser Photocoagulator GYC-500?

Green Laser Photocoagulator GYC-500 is a medical device that received FDA 510(k) clearance on 2016-05-02. It is manufactured by Nidek Co., Ltd.. The 510(k) number is K152603.

When was Green Laser Photocoagulator GYC-500 approved by the FDA?

Green Laser Photocoagulator GYC-500 received FDA 510(k) clearance on 2016-05-02, under approval number K152603.

What company makes Green Laser Photocoagulator GYC-500?

Green Laser Photocoagulator GYC-500 is manufactured by Nidek Co., Ltd..

What is the FDA product code for Green Laser Photocoagulator GYC-500?

The FDA product code for Green Laser Photocoagulator GYC-500 is HQF.

Related Clinical Trials

NCT07609888 Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis: A Randomized Split-Mouth Study COMPLETED

Other Devices by Nidek Co., Ltd.

K152729MICROPERIMETER MP-3 K151706Specular Microscope CEM- 530 K170302YELLOW LASER PHOTOCOAGULATOR YLC-500 K163564SLIT LAMP SL-2000 K181345Image Filing Software NAVIS-EX K173980Specular Microscope CEM-530

View all 12 devices →

Related Devices (Code: HQF)

K153769R:GEN Laser SystemLutronic Corporation K152688LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation K171488PSLT for PASCAL StreamlineTopcon Medical Laser Systems, Inc. K170067EasyretQuantel Medical K170302YELLOW LASER PHOTOCOAGULATOR YLC-500Nidek Co., Ltd. K180402PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStarTopcon Medical Laser Systems, Inc.

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.

↑