FDA 510(k)

R:GEN 激光系统

K号: K153769 · 2016-10-05

决定日期2016-10-05

产品代码HQF

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决定实质等同

器械摘要

R:GEN Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Lutronic Corporation. It received FDA 510(k) clearance on 2016-10-05 under 510(k) number K153769. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the R:GEN Laser System?

R:GEN Laser System is a medical device that received FDA 510(k) clearance on 2016-10-05. The listed applicant is Lutronic Corporation. The 510(k) number is K153769.

When did R:GEN Laser System receive FDA 510(k) clearance?

R:GEN Laser System received FDA 510(k) clearance on 2016-10-05, under 510(k) number K153769.

Who is the listed applicant for R:GEN Laser System?

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

What is the FDA product code for R:GEN Laser System?

The FDA product code for R:GEN Laser System is HQF.

列明Lutronic Corporation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。

K251327XERF K244060eCO2 3D K213748CoreLevee K213569HOLLYWOOD SPECTRA 激光系统 K203788DermaV 激光系统 K183566CLARITY II 激光系统

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官方来源

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