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FDA 510(k)

Sutil Luxe个人润滑剂（型号1126，0009，0010，0011）；Sutil Luxe香草个人润滑剂（型号1119，1120）；Sutil Luxe椰子个人润滑剂（型号1121，1122）；Sutil Luxe薄荷个人润滑剂（型号1117，1118）

K号: K241443 · 2025-01-21

申请人Hathor Professional Skincare , Ltd.
决定日期2025-01-21
产品代码NUC
咨询委员会OB 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同

器械摘要

Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118) 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 2025-01-21 under 510(k) number K241443. The device is classified under product code NUC. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118)?

Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118) is a medical device that received FDA 510(k) clearance on 2025-01-21. The listed applicant is Hathor Professional Skincare , Ltd.. The 510(k) number is K241443.

When did Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118) receive FDA 510(k) clearance?

Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118) received FDA 510(k) clearance on 2025-01-21, under 510(k) number K241443.

Who is the listed applicant for Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118)?

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 Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118)?

The FDA product code for Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118) is NUC.

相关临床试验

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Hathor Professional Skincare , Ltd.为申报人的其他记录

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。

K252914Sutil Pure个人润滑剂（型号1148，1145，1146，1147）K250629Sutil Rich个人润滑剂

相关器械（代码：NUC）

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。

K260117EverslideSpecial Situations, LLCK253989HARU Orgasm 杰克·赫尔水基润滑剂（WL-OJ）；HARU Orgasm 水基润滑剂（WL-OR）；HARU STEAMY 水基润滑剂（WL-ST）Maxigen Biotech, Inc.K261905BUM油Bumlicious, LLC (DBA “Bumlicious”)K261177PINKSLIP水基个人润滑剂和保湿剂PINKSLIP, LLCK261909Plum Vagiceuticals® 阴道保湿栓PCCA, Inc.K254011Flow Water-Based Personal LubricantLBDO Group, Inc.

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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