SnugLit™ 穿戴式光療系統 (SNGL-01-US)
K 號：K251308 · 2026-01-15
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決定日期2026-01-15
產品代碼LBI
諮詢委員會醫療設備規範文本翻譯如下：
HO
注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。
決定相當於
器材摘要
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.
常見問題
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.
相關臨床試驗
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相關器械（代碼：LBI）
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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