FDA 510(k)

Joylux インティマシティジェル（PG3100）

K番号: K242958 · 2025-03-20

決定日2025-03-20

製品コードNUC

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OB [翻訳] OB

決定大幅同等

医療機器の概要

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.

よくある質問

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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Joylux インティマシティジェル（PG3100）

医療機器の概要

よくある質問

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