PRO Pen微针治疗系统（6883）
K号: K243800 · 2025-08-25
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器械摘要
PRO Pen Microneedling System (6883) is the device name listed in this FDA 510(k) record. The listed applicant is Dermalogica, LLC. It received FDA 510(k) clearance on 2025-08-25 under 510(k) number K243800. 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 PRO Pen Microneedling System (6883)?
PRO Pen Microneedling System (6883) is a medical device that received FDA 510(k) clearance on 2025-08-25. The listed applicant is Dermalogica, LLC. The 510(k) number is K243800.
When did PRO Pen Microneedling System (6883) receive FDA 510(k) clearance?
PRO Pen Microneedling System (6883) received FDA 510(k) clearance on 2025-08-25, under 510(k) number K243800.
Who is the listed applicant for PRO Pen Microneedling System (6883)?
The FDA 510(k) record lists Dermalogica, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PRO Pen Microneedling System (6883)?
The FDA product code for PRO Pen Microneedling System (6883) 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。
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。
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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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