Erchonia EVRL
K号: K251843 · 2025-09-12
广告
决定日期2025-09-12
产品代码OLP
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
Erchonia EVRL is the device name listed in this FDA 510(k) record. The listed applicant is Erchonia Corporation. It received FDA 510(k) clearance on 2025-09-12 under 510(k) number K251843. 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 Erchonia EVRL?
Erchonia EVRL is a medical device that received FDA 510(k) clearance on 2025-09-12. The listed applicant is Erchonia Corporation. The 510(k) number is K251843.
When did Erchonia EVRL receive FDA 510(k) clearance?
Erchonia EVRL received FDA 510(k) clearance on 2025-09-12, under 510(k) number K251843.
Who is the listed applicant for Erchonia EVRL?
The FDA 510(k) record lists Erchonia Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Erchonia EVRL?
The FDA product code for Erchonia EVRL 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Erchonia Corporation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.K242068LED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.K230720LUSTRE 3XPRESS 光美疗贴片，型号：PR6001，PR5001Light Tree Ventures Europe B.V.
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。
广告