FDA 510(k)

Pulsaderm Acne Device

K号: K161941 · 2016-10-19

决定日期2016-10-19

产品代码OLP

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决定实质等同

器械摘要

Pulsaderm Acne Device is the device name listed in this FDA 510(k) record. The listed applicant is Nutra Luxe MD, LLC. It received FDA 510(k) clearance on 2016-10-19 under 510(k) number K161941. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Pulsaderm Acne Device?

Pulsaderm Acne Device is a medical device that received FDA 510(k) clearance on 2016-10-19. The listed applicant is Nutra Luxe MD, LLC. The 510(k) number is K161941.

When did Pulsaderm Acne Device receive FDA 510(k) clearance?

Pulsaderm Acne Device received FDA 510(k) clearance on 2016-10-19, under 510(k) number K161941.

Who is the listed applicant for Pulsaderm Acne Device?

The FDA 510(k) record lists Nutra Luxe MD, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pulsaderm Acne Device?

The FDA product code for Pulsaderm Acne Device is OLP.

列明Nutra Luxe MD, LLC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。

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相关器械（代码：OLP）

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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