IPL治疗系统
K号: K200746 · 2020-05-15
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决定日期2020-05-15
产品代码ONF
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
IPL Treatment Systems is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-05-15 under 510(k) number K200746. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the IPL Treatment Systems?
IPL Treatment Systems is a medical device that received FDA 510(k) clearance on 2020-05-15. The listed applicant is Shanghai Apolo Medical Technology Co., Ltd.. The 510(k) number is K200746.
When did IPL Treatment Systems receive FDA 510(k) clearance?
IPL Treatment Systems received FDA 510(k) clearance on 2020-05-15, under 510(k) number K200746.
Who is the listed applicant for IPL Treatment Systems?
The FDA 510(k) record lists Shanghai Apolo Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for IPL Treatment Systems?
The FDA product code for IPL Treatment Systems is ONF.
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。
列明Shanghai Apolo Medical Technology Co., 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。
相关器械（代码：ONF）
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。
K261204强脉冲光治疗设备Sanhe LEFIS Electronics Co., Ltd.K251545强脉冲光治疗设备（MMABM-1）Micowey Medical Equipment (Guangxi) Co., Ltd.K231952MEDILIGHTMedicreations, LLCK243123IPL治疗设备（MDSQMC-01）Medusa (Guangxi)Medical Devices Co., Ltd.K250281DEKA LOTUSEl.En S.P.A.K242440强脉冲光治疗系统（LK-PT）Nanjing Bestview Laser S&T Co., Ltd.
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。
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