IPL 髮毛去除器
K 號：K222316 · 2022-09-28
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決定日期2022-09-28
產品代碼OHT
諮詢委員會SU
請提供完整的描述文本，以便我進行翻譯。
決定相當於
器材摘要
IPL Hair Removal Device is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Goodwind Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2022-09-28 under 510(k) number K222316. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the IPL Hair Removal Device?
IPL Hair Removal Device is a medical device that received FDA 510(k) clearance on 2022-09-28. The listed applicant is Shenzhen Goodwind Technology Development Co., Ltd.. The 510(k) number is K222316.
When did IPL Hair Removal Device receive FDA 510(k) clearance?
IPL Hair Removal Device received FDA 510(k) clearance on 2022-09-28, under 510(k) number K222316.
Who is the listed applicant for IPL Hair Removal Device?
FDA 510(k) 記錄將深圳好風科技開發有限公司列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for IPL Hair Removal Device?
The FDA product code for IPL Hair Removal Device is OHT.
相關臨床試驗
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。
其他以 Shenzhen Goodwind Technology Development Co., Ltd. 為申請人之記錄
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。
相關器械（代碼：OHT）
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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