DEKA LOTUS
K号: K233473 · 2024-05-16
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器械摘要
DEKA LOTUS is the device name listed in this FDA 510(k) record. The listed applicant is El.En S.P.A.. It received FDA 510(k) clearance on 2024-05-16 under 510(k) number K233473. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the DEKA LOTUS?
DEKA LOTUS is a medical device that received FDA 510(k) clearance on 2024-05-16. The listed applicant is El.En S.P.A.. The 510(k) number is K233473.
When did DEKA LOTUS receive FDA 510(k) clearance?
DEKA LOTUS received FDA 510(k) clearance on 2024-05-16, under 510(k) number K233473.
Who is the listed applicant for DEKA LOTUS?
The FDA 510(k) record lists El.En S.P.A. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DEKA LOTUS?
The FDA product code for DEKA LOTUS is ONF.
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。
列明El.En S.P.A.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。
相关器械（代码：ONF）
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。
K261204强脉冲光治疗设备Sanhe LEFIS Electronics Co., Ltd.K251545强脉冲光治疗设备（MMABM-1）Micowey Medical Equipment (Guangxi) Co., Ltd.K231952MEDILIGHTMedicreations, LLCK243123IPL治疗设备（MDSQMC-01）Medusa (Guangxi)Medical Devices Co., Ltd.K250281DEKA LOTUSEl.En S.P.A.K242440强脉冲光治疗系统（LK-PT）Nanjing Bestview Laser S&T Co., Ltd.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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