SnugLit™可穿戴光疗系统（SNGL-01-US）
K号: K251308 · 2026-01-15
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决定日期2026-01-15
产品代码LBI
咨询委员会医疗设备监管文本翻译如下：
HO
请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。
决定实质等同
器械摘要
SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) is the device name listed in this FDA 510(k) record. The listed applicant is Thera B Medical Products. It received FDA 510(k) clearance on 2026-01-15 under 510(k) number K251308. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)?
SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) is a medical device that received FDA 510(k) clearance on 2026-01-15. The listed applicant is Thera B Medical Products. The 510(k) number is K251308.
When did SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) receive FDA 510(k) clearance?
SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) received FDA 510(k) clearance on 2026-01-15, under 510(k) number K251308.
Who is the listed applicant for SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)?
The FDA 510(k) record lists Thera B Medical Products as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)?
The FDA product code for SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) is LBI.
相关临床试验
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相关器械（代码：LBI）
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。
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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