FDA 510(k)

HeatLux Pro II

K号: K152087 · 2016-07-29

决定日期2016-07-29

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

HeatLux Pro II is the device name listed in this FDA 510(k) record. The listed applicant is Home Skinovations , Ltd.. It received FDA 510(k) clearance on 2016-07-29 under 510(k) number K152087. 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 HeatLux Pro II?

HeatLux Pro II is a medical device that received FDA 510(k) clearance on 2016-07-29. The listed applicant is Home Skinovations , Ltd.. The 510(k) number is K152087.

When did HeatLux Pro II receive FDA 510(k) clearance?

HeatLux Pro II received FDA 510(k) clearance on 2016-07-29, under 510(k) number K152087.

Who is the listed applicant for HeatLux Pro II?

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

What is the FDA product code for HeatLux Pro II?

The FDA product code for HeatLux Pro II is ILY.

列明Home Skinovations , Ltd.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。

K214078Silk’n Toothwave K180279Silk'n MODEL H5003设备 K171433Silk'n Infinity K162784Silk'n HST

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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。