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FDA 510(k)

HealthLight 微控制器型号 HL-FB (足床), HL-HB (头带) 和 HL-FM (面罩) LED 光疗系统

K号: K163079 · 2017-06-13

申请人Healthlight, LLC
决定日期2017-06-13
产品代码ILY
咨询委员会PM 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System is the device name listed in this FDA 510(k) record. The listed applicant is Healthlight, LLC. It received FDA 510(k) clearance on 2017-06-13 under 510(k) number K163079. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System?

HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System is a medical device that received FDA 510(k) clearance on 2017-06-13. The listed applicant is Healthlight, LLC. The 510(k) number is K163079.

When did HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System receive FDA 510(k) clearance?

HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System received FDA 510(k) clearance on 2017-06-13, under 510(k) number K163079.

Who is the listed applicant for HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System?

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

What is the FDA product code for HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System?

The FDA product code for HealthLight Microcontroller Models HL-FB (Footbed), HL-HB (Headband) and HL-FM (Facemask) LED Light Therapy System is ILY.

相关临床试验

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：ILY）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K253965CureLight 医疗二极管激光系统（CureLight F2-A15；CureLight F2-B15；CureLight F2-A30；CureLight F2-B30；CureLight F3-AB30；CureLight F3-AB60）Wuhan PHOMED Technology Company , Ltd.K242755医疗二极管激光系统（VELAS II-30B，VELAS II-30A，GBOX-15AB，GBOX-20B，CHEESE II-10B）Gigaalaser Company , Ltd.K231997SIRONA 100 治疗激光系统 (OEM的型号 EVANLAS)Cure Point Therapeutics, Inc.K223642LED唇部修护仪，型号：ZC-05Light Tree Ventures Europe B.V.K221189OLIZ LTB-1000ALtbio Co., Ltd.K213524CytonPro-5000Cytonsys, Inc.

官方来源

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