FDA 510(k)

Exciplex308nm

K号: K171702 · 2017-10-13

决定日期2017-10-13

产品代码FTC

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决定实质等同

器械摘要

Exciplex308nm is the device name listed in this FDA 510(k) record. The listed applicant is Clarteis. It received FDA 510(k) clearance on 2017-10-13 under 510(k) number K171702. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Exciplex308nm?

Exciplex308nm is a medical device that received FDA 510(k) clearance on 2017-10-13. The listed applicant is Clarteis. The 510(k) number is K171702.

When did Exciplex308nm receive FDA 510(k) clearance?

Exciplex308nm received FDA 510(k) clearance on 2017-10-13, under 510(k) number K171702.

Who is the listed applicant for Exciplex308nm?

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

What is the FDA product code for Exciplex308nm?

The FDA product code for Exciplex308nm is FTC.

列明Clarteis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。

K191086Exciplex

相关器械（代码：FTC）

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。

K254234光疗系统 (DUV-COMBO)Choyang Medics Co., Ltd.K253871Klär Lite（RCW-KL1000）Radcliffe Watts, LLC K250425紫外线光疗设备APK Technology Co., Ltd.K244022308nm紫外线光疗系统（UV-K）；308nm紫外线光疗系统（UV-X）；308nm紫外线光疗系统（UV-Y）；308nm紫外线光疗系统（UV-Z）Boston Aesthetics, Inc.K242977308nm准分子光疗设备（CN-308E，KN-4003B3，KN-4003B4，KN-5000C KN-5000D，KN-5000H，KN-5000K）Xuzhou Kernel Medical Equipment Co., Ltd.K242908紫外线光疗设备（A组：SQ308PCHFD，SQ308PCQFD，SQ308PCPFD，SQ308PCNFD，SQ308PCMFD）；紫外线光疗设备（B组：SQ308PHTFF，SQ308PHSFF，SQ308PHRFF，SQ308PHZFG，SQ308PPUFF，SQ308PPVFF，SQ308PPWFG）Shanghai Sigma High-Tech Co., Ltd.

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