SkinPen Precision Elite System
K号: K241400 · 2024-08-29
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器械摘要
SkinPen Precision Elite System is the device name listed in this FDA 510(k) record. The listed applicant is Crown Aesthetics. It received FDA 510(k) clearance on 2024-08-29 under 510(k) number K241400. The device is classified under product code QAI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SkinPen Precision Elite System?
SkinPen Precision Elite System is a medical device that received FDA 510(k) clearance on 2024-08-29. The listed applicant is Crown Aesthetics. The 510(k) number is K241400.
When did SkinPen Precision Elite System receive FDA 510(k) clearance?
SkinPen Precision Elite System received FDA 510(k) clearance on 2024-08-29, under 510(k) number K241400.
Who is the listed applicant for SkinPen Precision Elite System?
The FDA 510(k) record lists Crown Aesthetics as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SkinPen Precision Elite System?
The FDA product code for SkinPen Precision Elite System is QAI.
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。
列明Crown Aesthetics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：QAI）
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。
K252591自动微针系统（CODE-X）Woorhi Mechatronics Co., Ltd.K253002SkinStylus SteriLock MicroSystem (MP1209SL)Esthetic Medical, Inc.K252752艾拉科尔系统，配备微孔技术Cytrellis Biosystems, Inc.K253153SER Pen Carain 微系统 (MP1209SP)Su-Ko Technologies, LLCK243800PRO Pen微针治疗系统（6883）Dermalogica, LLCK243143E-PEN (E-PEN)Bomtech Electronics Co., Ltd.
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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