FDA 510(k)

医用非剥脱性点阵激光系统

K号: K192350 · 2020-04-30

决定日期2020-04-30

产品代码ONG

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决定实质等同

器械摘要

Medical Non-Ablative Fractional Laser Systems is the device name listed in this FDA 510(k) record. The listed applicant is Wingderm Electro-Optics , Ltd.. It received FDA 510(k) clearance on 2020-04-30 under 510(k) number K192350. The device is classified under product code ONG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Medical Non-Ablative Fractional Laser Systems?

Medical Non-Ablative Fractional Laser Systems is a medical device that received FDA 510(k) clearance on 2020-04-30. The listed applicant is Wingderm Electro-Optics , Ltd.. The 510(k) number is K192350.

When did Medical Non-Ablative Fractional Laser Systems receive FDA 510(k) clearance?

Medical Non-Ablative Fractional Laser Systems received FDA 510(k) clearance on 2020-04-30, under 510(k) number K192350.

Who is the listed applicant for Medical Non-Ablative Fractional Laser Systems?

The FDA 510(k) record lists Wingderm Electro-Optics , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Non-Ablative Fractional Laser Systems?

The FDA product code for Medical Non-Ablative Fractional Laser Systems is ONG.

列明Wingderm Electro-Optics , 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。

K252599二极管激光治疗系统（WLA-02）K191611二极管激光治疗系统

官方来源

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