IPL + 二极管激光机
K号: K193328 · 2020-03-25
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决定日期2020-03-25
产品代码ONF
咨询委员会SU
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决定实质等同
器械摘要
IPL + Diode Laser Machine is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Globalipl Development Co., Ltd.. It received FDA 510(k) clearance on 2020-03-25 under 510(k) number K193328. 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 + Diode Laser Machine?
IPL + Diode Laser Machine is a medical device that received FDA 510(k) clearance on 2020-03-25. The listed applicant is Beijing Globalipl Development Co., Ltd.. The 510(k) number is K193328.
When did IPL + Diode Laser Machine receive FDA 510(k) clearance?
IPL + Diode Laser Machine received FDA 510(k) clearance on 2020-03-25, under 510(k) number K193328.
Who is the listed applicant for IPL + Diode Laser Machine?
The FDA 510(k) record lists Beijing Globalipl Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for IPL + Diode Laser Machine?
The FDA product code for IPL + Diode Laser Machine is ONF.
相关临床试验
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列明Beijing Globalipl Development 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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