PureLift Pro Edition
K号: K230506 · 2023-06-21
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申请人Xtreem Pulse
决定日期2023-06-21
产品代码NFO
咨询委员会NE
请注意，您提供的文本“NE”不足以进行翻译，因为它不是一个完整的句子或描述。请提供完整的医疗设备监管文本，以便我能够进行准确的翻译。
决定实质等同
器械摘要
PureLift Pro Edition is the device name listed in this FDA 510(k) record. The listed applicant is Xtreem Pulse. It received FDA 510(k) clearance on 2023-06-21 under 510(k) number K230506. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the PureLift Pro Edition?
PureLift Pro Edition is a medical device that received FDA 510(k) clearance on 2023-06-21. The listed applicant is Xtreem Pulse. The 510(k) number is K230506.
When did PureLift Pro Edition receive FDA 510(k) clearance?
PureLift Pro Edition received FDA 510(k) clearance on 2023-06-21, under 510(k) number K230506.
Who is the listed applicant for PureLift Pro Edition?
The FDA 510(k) record lists Xtreem Pulse as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PureLift Pro Edition?
The FDA product code for PureLift Pro Edition is NFO.
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。
相关器械（代码：NFO）
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。
K261370LED光疗面罩（LED面部脉冲面罩（FAC06NA））Guangdong Newdermo Biotech Co., Ltd.K262861PureLift Pro MaxXtreem Pulse, LLCK260387SYNERJET PRO (SP-1003)；InPhiuse (SP-1003)；WOWJET (SP-1003)Hironic Co., Ltd.K253932FACEGYM Pro 设备（HD-109）Shenzhen Kaiyan Medical Equipment Co., Ltd.K260179VITA多功能头部刷（TB-2343F，TB-2442F）Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.K260895优立克清零（YC10 BU）Guangxi Ulike Medical Technology Co., Ltd.
官方来源
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