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FDA 510(k)

NIRA 美容皮肤激光

K号: K163137 · 2017-07-12

决定日期2017-07-12
产品代码OHS
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决定实质等同

器械摘要

NIRA Beauty Skin Laser is the device name listed in this FDA 510(k) record. The listed applicant is Dermal Photonics Corporation. It received FDA 510(k) clearance on 2017-07-12 under 510(k) number K163137. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NIRA Beauty Skin Laser?

NIRA Beauty Skin Laser is a medical device that received FDA 510(k) clearance on 2017-07-12. The listed applicant is Dermal Photonics Corporation. The 510(k) number is K163137.

When did NIRA Beauty Skin Laser receive FDA 510(k) clearance?

NIRA Beauty Skin Laser received FDA 510(k) clearance on 2017-07-12, under 510(k) number K163137.

Who is the listed applicant for NIRA Beauty Skin Laser?

The FDA 510(k) record lists Dermal Photonics Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NIRA Beauty Skin Laser?

The FDA product code for NIRA Beauty Skin Laser is OHS.

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相关器械(代码:OHS)

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。

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