强脉冲光治疗设备
K号: K261204 · 2026-06-12
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决定日期2026-06-12
产品代码ONF
咨询委员会SU
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器械摘要
Intense Pulsed Light Therapy Device is the device name listed in this FDA 510(k) record. The listed applicant is Sanhe LEFIS Electronics Co., Ltd.. It received FDA 510(k) clearance on 2026-06-12 under 510(k) number K261204. 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 Therapy Device?
Intense Pulsed Light Therapy Device is a medical device that received FDA 510(k) clearance on 2026-06-12. The listed applicant is Sanhe LEFIS Electronics Co., Ltd.. The 510(k) number is K261204.
When did Intense Pulsed Light Therapy Device receive FDA 510(k) clearance?
Intense Pulsed Light Therapy Device received FDA 510(k) clearance on 2026-06-12, under 510(k) number K261204.
Who is the listed applicant for Intense Pulsed Light Therapy Device?
FDA 510(k)记录将三和乐福斯电子有限公司列为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for Intense Pulsed Light Therapy Device?
The FDA product code for Intense Pulsed Light Therapy Device 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Sanhe LEFIS Electronics 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。
K251545强脉冲光治疗设备（MMABM-1）Micowey Medical Equipment (Guangxi) Co., Ltd.K231952MEDILIGHTMedicreations, LLCK243123IPL治疗设备（MDSQMC-01）Medusa (Guangxi)Medical Devices Co., Ltd.K250281DEKA LOTUSEl.En S.P.A.K242440强脉冲光治疗系统（LK-PT）Nanjing Bestview Laser S&T Co., Ltd.K240314MULA (K2-A1)Guangzhou Ciellulu Photoelectric 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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