Harmony XL多应用平台
K号: K181298 · 2018-06-13
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器械摘要
Harmony XL Multi-Application Platform is the device name listed in this FDA 510(k) record. The listed applicant is Alma Lasers, Inc.. It received FDA 510(k) clearance on 2018-06-13 under 510(k) number K181298. 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 Harmony XL Multi-Application Platform?
Harmony XL Multi-Application Platform is a medical device that received FDA 510(k) clearance on 2018-06-13. The listed applicant is Alma Lasers, Inc.. The 510(k) number is K181298.
When did Harmony XL Multi-Application Platform receive FDA 510(k) clearance?
Harmony XL Multi-Application Platform received FDA 510(k) clearance on 2018-06-13, under 510(k) number K181298.
Who is the listed applicant for Harmony XL Multi-Application Platform?
The FDA 510(k) record lists Alma Lasers, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Harmony XL Multi-Application Platform?
The FDA product code for Harmony XL Multi-Application Platform 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Alma Lasers, Inc.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。
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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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