OPXION光學皮膚檢視器（OPXSV1-01F）
K 號：K242924 · 2025-06-23
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器材摘要
OPXION Optical Skin Viewer (OPXSV1-01F) is the device name listed in this FDA 510(k) record. The listed applicant is Opxion Technology, Inc.. It received FDA 510(k) clearance on 2025-06-23 under 510(k) number K242924. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the OPXION Optical Skin Viewer (OPXSV1-01F)?
OPXION Optical Skin Viewer (OPXSV1-01F) is a medical device that received FDA 510(k) clearance on 2025-06-23. The listed applicant is Opxion Technology, Inc.. The 510(k) number is K242924.
When did OPXION Optical Skin Viewer (OPXSV1-01F) receive FDA 510(k) clearance?
OPXION Optical Skin Viewer (OPXSV1-01F) received FDA 510(k) clearance on 2025-06-23, under 510(k) number K242924.
Who is the listed applicant for OPXION Optical Skin Viewer (OPXSV1-01F)?
The FDA 510(k) record lists Opxion Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OPXION Optical Skin Viewer (OPXSV1-01F)?
The FDA product code for OPXION Optical Skin Viewer (OPXSV1-01F) is NQQ.
相關臨床試驗
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相關器械（代碼：NQQ）
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。
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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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