FDA 510(k)

Sutil純個人潤滑劑（型號1148、1145、1146、1147）

K 號：K252914 · 2026-06-09

決定日期2026-06-09

產品代碼NUC

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) is the device name listed in this FDA 510(k) record. The listed applicant is Hathor Professional Skincare , Ltd.. It received FDA 510(k) clearance on 2026-06-09 under 510(k) number K252914. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)?

Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) is a medical device that received FDA 510(k) clearance on 2026-06-09. The listed applicant is Hathor Professional Skincare , Ltd.. The 510(k) number is K252914.

When did Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) receive FDA 510(k) clearance?

Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) received FDA 510(k) clearance on 2026-06-09, under 510(k) number K252914.

Who is the listed applicant for Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)?

The FDA 510(k) record lists Hathor Professional Skincare , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)?

The FDA product code for Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) is NUC.

其他以 Hathor Professional Skincare , 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。

K250629Sutil Rich 個人潤滑劑 K241443Sutil Luxe 個人潤滑劑（型號 1126、0009、0010、0011）；Sutil Luxe 薄荷個人潤滑劑（型號 1119、1120）；Sutil Luxe 椰子個人潤滑劑（型號 1121、1122）；Sutil Luxe 薄荷個人潤滑劑（型號 1117、1118）

相關器械（代碼：NUC）

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。

K260117EverslideSpecial Situations, LLC K253989HARU Orgasm by jack herer 水基潤滑劑（WL-OJ）；HARU Orgasm 水基潤滑劑（WL-OR）；HARU STEAMY 水基潤滑劑（WL-ST）Maxigen Biotech, Inc.K261905BUM油Bumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP 水基個人潤滑劑及保濕劑PINKSLIP, LLC K261909Plum Vagiceuticals™ 阴道潤滑栓PCCA, Inc.K254011流動水性個人潤滑劑LBDO Group, Inc.

官方來源

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