truSculpt flex
K号: K212866 · 2022-12-03
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决定日期2022-12-03
产品代码NGX
咨询委员会PM
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决定实质等同
器械摘要
truSculpt flex is the device name listed in this FDA 510(k) record. The listed applicant is Johari Digital Healthcare Limited. It received FDA 510(k) clearance on 2022-12-03 under 510(k) number K212866. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the truSculpt flex?
truSculpt flex is a medical device that received FDA 510(k) clearance on 2022-12-03. The listed applicant is Johari Digital Healthcare Limited. The 510(k) number is K212866.
When did truSculpt flex receive FDA 510(k) clearance?
truSculpt flex received FDA 510(k) clearance on 2022-12-03, under 510(k) number K212866.
Who is the listed applicant for truSculpt flex?
The FDA 510(k) record lists Johari Digital Healthcare Limited as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for truSculpt flex?
The FDA product code for truSculpt flex is NGX.
相关临床试验
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列明Johari Digital Healthcare Limited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：NGX）
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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