ESPADA 痤疮清除蓝光笔
K号: K162450 · 2016-11-30
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器械摘要
ESPADA Acne-Clearing Blue Light Pen is the device name listed in this FDA 510(k) record. The listed applicant is Foreo, Inc.. It received FDA 510(k) clearance on 2016-11-30 under 510(k) number K162450. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ESPADA Acne-Clearing Blue Light Pen?
ESPADA Acne-Clearing Blue Light Pen is a medical device that received FDA 510(k) clearance on 2016-11-30. The listed applicant is Foreo, Inc.. The 510(k) number is K162450.
When did ESPADA Acne-Clearing Blue Light Pen receive FDA 510(k) clearance?
ESPADA Acne-Clearing Blue Light Pen received FDA 510(k) clearance on 2016-11-30, under 510(k) number K162450.
Who is the listed applicant for ESPADA Acne-Clearing Blue Light Pen?
The FDA 510(k) record lists Foreo, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ESPADA Acne-Clearing Blue Light Pen?
The FDA product code for ESPADA Acne-Clearing Blue Light Pen is OLP.
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Foreo, Inc.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：OLP）
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。
K253878LUSTRE GoGlow 高级 LED 贴片（PR8001，PR9001）Shenzhen Kaiyan Medical Equipment Co., Ltd.K251843Erchonia EVRLErchonia CorporationK242068LED光疗面罩（RT01）Ningbo Dechang Electrical Machinery Made Co.,LtdK243555LED光疗面罩（E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A）Shenzhen Eyco Technology Co., Ltd.K232656BLU TOTALE (型号：ENEOB852)Premier North America, Inc.K230490PMD Clean痤疮清洁，型号：4004-CABLUE-NA，4004-GREY-NA，4004-YELLOW-NA，4004-PSTO-NA，4004-LPUR-NA，4004-CABLUE-NA-INT，4004-GREY-INT，4004-YELLOW-INT，4004-PSTO-INT，4004-LPUR-INTDongguan Hunter Electronic Technology 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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