BodySculp
K号: K212331 · 2021-11-09
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决定日期2021-11-09
产品代码PKT
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。
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器械摘要
BodySculp is the device name listed in this FDA 510(k) record. The listed applicant is Rohrer Aesthetics, LLC. It received FDA 510(k) clearance on 2021-11-09 under 510(k) number K212331. The device is classified under product code PKT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BodySculp?
BodySculp is a medical device that received FDA 510(k) clearance on 2021-11-09. The listed applicant is Rohrer Aesthetics, LLC. The 510(k) number is K212331.
When did BodySculp receive FDA 510(k) clearance?
BodySculp received FDA 510(k) clearance on 2021-11-09, under 510(k) number K212331.
Who is the listed applicant for BodySculp?
The FDA 510(k) record lists Rohrer Aesthetics, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BodySculp?
The FDA product code for BodySculp is PKT.
相关临床试验
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列明Rohrer Aesthetics, LLC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：PKT）
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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