FDA 510(k)

LightStim专业LED床

K号: K153399 · 2016-07-05

决定日期2016-07-05

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

LightStim Professional LED Bed is the device name listed in this FDA 510(k) record. The listed applicant is Led Intellectual Properties, LLC. It received FDA 510(k) clearance on 2016-07-05 under 510(k) number K153399. 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 LightStim Professional LED Bed?

LightStim Professional LED Bed is a medical device that received FDA 510(k) clearance on 2016-07-05. The listed applicant is Led Intellectual Properties, LLC. The 510(k) number is K153399.

When did LightStim Professional LED Bed receive FDA 510(k) clearance?

LightStim Professional LED Bed received FDA 510(k) clearance on 2016-07-05, under 510(k) number K153399.

Who is the listed applicant for LightStim Professional LED Bed?

FDA 510(k)记录显示Led Intellectual Properties, LLC为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for LightStim Professional LED Bed?

The FDA product code for LightStim Professional LED Bed is ILY.

列明Led Intellectual Properties, LLC为申报人的其他记录

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。

K261482LightStim抗皱仪（1984年）；LightStim祛痘仪（2038年）K212771LightStim Elipsa

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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