Thermage FLX 系统及附件
K号: K170758 · 2017-09-22
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器械摘要
Thermage FLX System and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Solta Medical. It received FDA 510(k) clearance on 2017-09-22 under 510(k) number K170758. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Thermage FLX System and Accessories?
Thermage FLX System and Accessories is a medical device that received FDA 510(k) clearance on 2017-09-22. The listed applicant is Solta Medical. The 510(k) number is K170758.
When did Thermage FLX System and Accessories receive FDA 510(k) clearance?
Thermage FLX System and Accessories received FDA 510(k) clearance on 2017-09-22, under 510(k) number K170758.
Who is the listed applicant for Thermage FLX System and Accessories?
The FDA 510(k) record lists Solta Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Thermage FLX System and Accessories?
The FDA product code for Thermage FLX System and Accessories is GEI.
相关临床试验
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列明Solta Medical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：GEI）
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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