强脉冲光设备
K号: K220385 · 2022-08-12
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决定日期2022-08-12
产品代码ONF
咨询委员会SU
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决定实质等同
器械摘要
Intense Pulsed Light Equipment is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Globalipl Development Co., Ltd.. It received FDA 510(k) clearance on 2022-08-12 under 510(k) number K220385. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Intense Pulsed Light Equipment?
Intense Pulsed Light Equipment is a medical device that received FDA 510(k) clearance on 2022-08-12. The listed applicant is Beijing Globalipl Development Co., Ltd.. The 510(k) number is K220385.
When did Intense Pulsed Light Equipment receive FDA 510(k) clearance?
Intense Pulsed Light Equipment received FDA 510(k) clearance on 2022-08-12, under 510(k) number K220385.
Who is the listed applicant for Intense Pulsed Light Equipment?
The FDA 510(k) record lists Beijing Globalipl Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Intense Pulsed Light Equipment?
The FDA product code for Intense Pulsed Light Equipment is ONF.
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Beijing Globalipl Development Co., Ltd.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：ONF）
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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