Medicell Mycosis 激光器（MCML24004）
K号: K253960 · 2026-03-09
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决定日期2026-03-09
产品代码PDZ
咨询委员会SU
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决定实质等同
器械摘要
Medicell Mycosis Laser (MCML24004) is the device name listed in this FDA 510(k) record. The listed applicant is Medicell Healthcare Co.,LTD. It received FDA 510(k) clearance on 2026-03-09 under 510(k) number K253960. The device is classified under product code PDZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Medicell Mycosis Laser (MCML24004)?
Medicell Mycosis Laser (MCML24004) is a medical device that received FDA 510(k) clearance on 2026-03-09. The listed applicant is Medicell Healthcare Co.,LTD. The 510(k) number is K253960.
When did Medicell Mycosis Laser (MCML24004) receive FDA 510(k) clearance?
Medicell Mycosis Laser (MCML24004) received FDA 510(k) clearance on 2026-03-09, under 510(k) number K253960.
Who is the listed applicant for Medicell Mycosis Laser (MCML24004)?
The FDA 510(k) record lists Medicell Healthcare Co.,LTD as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Medicell Mycosis Laser (MCML24004)?
The FDA product code for Medicell Mycosis Laser (MCML24004) is PDZ.
相关临床试验
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相关器械（代码：PDZ）
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。
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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