超塑系统
K号: K161952 · 2016-11-07
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决定日期2016-11-07
产品代码OHV
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
UltraShape System is the device name listed in this FDA 510(k) record. The listed applicant is Syneron Medical, Ltd.. It received FDA 510(k) clearance on 2016-11-07 under 510(k) number K161952. The device is classified under product code OHV. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the UltraShape System?
UltraShape System is a medical device that received FDA 510(k) clearance on 2016-11-07. The listed applicant is Syneron Medical, Ltd.. The 510(k) number is K161952.
When did UltraShape System receive FDA 510(k) clearance?
UltraShape System received FDA 510(k) clearance on 2016-11-07, under 510(k) number K161952.
Who is the listed applicant for UltraShape System?
The FDA 510(k) record lists Syneron Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for UltraShape System?
The FDA product code for UltraShape System is OHV.
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列明Syneron Medical, Ltd.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：OHV）
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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