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FDA 510(k)

晒黑灯

K号: K221523 · 2023-02-15

申请人Unilam Co., Ltd.
决定日期2023-02-15
产品代码LEJ
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Tanning Lamp is the device name listed in this FDA 510(k) record. The listed applicant is Unilam Co., Ltd.. It received FDA 510(k) clearance on 2023-02-15 under 510(k) number K221523. The device is classified under product code LEJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Tanning Lamp?

Tanning Lamp is a medical device that received FDA 510(k) clearance on 2023-02-15. The listed applicant is Unilam Co., Ltd.. The 510(k) number is K221523.

When did Tanning Lamp receive FDA 510(k) clearance?

Tanning Lamp received FDA 510(k) clearance on 2023-02-15, under 510(k) number K221523.

Who is the listed applicant for Tanning Lamp?

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

What is the FDA product code for Tanning Lamp?

The FDA product code for Tanning Lamp is LEJ.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

相关器械（代码：LEJ）

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。

K220500Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by ErgolineJk-Holding GmbHK191881KBL 7000 alpha hybridSun，KBL 7900 alpha hybridSun，KBL 8000 alpha hybridSunKbl GmbHK190173Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / SoundJk-Holding GmbHK183539Ergoline Sunrise 7200 Hybrid TechnologyJk-Holding GmbHK180555Ergoline Prestige 1600 Hybrid PerformanceJk Holding GmbHK181455ProSun 太阳灯产品，Luxura 太阳灯产品Prosun International, LLC

官方来源

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