Joylux 親密膠 (PG3100)
K 號：K242958 · 2025-03-20
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申請人Joylux, Inc.
決定日期2025-03-20
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
Joylux Intimacy Gel (PG3100) is the device name listed in this FDA 510(k) record. The listed applicant is Joylux, Inc.. It received FDA 510(k) clearance on 2025-03-20 under 510(k) number K242958. 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 Joylux Intimacy Gel (PG3100)?
Joylux Intimacy Gel (PG3100) is a medical device that received FDA 510(k) clearance on 2025-03-20. The listed applicant is Joylux, Inc.. The 510(k) number is K242958.
When did Joylux Intimacy Gel (PG3100) receive FDA 510(k) clearance?
Joylux Intimacy Gel (PG3100) received FDA 510(k) clearance on 2025-03-20, under 510(k) number K242958.
Who is the listed applicant for Joylux Intimacy Gel (PG3100)?
The FDA 510(k) record lists Joylux, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Joylux Intimacy Gel (PG3100)?
The FDA product code for Joylux Intimacy Gel (PG3100) is NUC.
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相關器械（代碼：NUC）
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官方來源
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