FDA 510(k)

LED光疗面罩（K9C-TK，K9C-K，K9P-YK，K9P-K，FM-03BK，FM-09K）

K号: K260946 · 2026-06-18

决定日期2026-06-18

产品代码OHS

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

LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Newdermo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2026-06-18 under 510(k) number K260946. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)?

LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) is a medical device that received FDA 510(k) clearance on 2026-06-18. The listed applicant is Guangdong Newdermo Biotech Co., Ltd.. The 510(k) number is K260946.

When did LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) receive FDA 510(k) clearance?

LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) received FDA 510(k) clearance on 2026-06-18, under 510(k) number K260946.

Who is the listed applicant for LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)?

FDA 510(k)记录将广东纽德美生物科技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 LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)?

The FDA product code for LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) is OHS.

列明Guangdong Newdermo Biotech 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。

K261370LED光疗面罩（LED面部脉冲面罩（FAC06NA））K261052LED光疗面罩（LED Face Mask Pro FAC08NA，LED Chest Mask Pro FAC09NA）K260202LED光疗面罩（LumiLips FAC07NA）K223544LED光疗面罩（FM-01, FM-02, FM-03）

相关器械（代码：OHS）

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。

K260767面部美容设备（面部面膜LED美容设备A-901；面部LED & EMS美容设备A-902；面部面膜LED & EMS美容设备A-907）Kam Yuen Plastic Products , Ltd.K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.K261601LED光疗面罩（M01、M02、M03、M05、M06、M07、M08）Shenzhen Chuangtong Yigou Technology Co., Ltd.K261851LED光疗面罩（JML1，JML1+JML2）；LED光疗面罩（JML3，JML3+JML4）；LED光疗面罩（JML5，JML5+JML7）；LED光疗面罩（JML6，JML6+JML8）；LED光疗面罩（JML9，JML9+JML10）Shenzhen Qianyu Technology Co., Ltd.K261496LED光疗面罩（PE748，PE749，PE756）Duplex International Trading Limited K261482LightStim抗皱仪（1984年）；LightStim祛痘仪（2038年）Led Intellectual Properties, LLC

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。