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Joylux Intimacy Gel (PG3100)

by Joylux, Inc. 510(k)

Active United States

510(k) K242958

Overview

Joylux Intimacy Gel (PG3100) is a water-based personal lubricant intended for penile and/or vaginal application to lubricate and moisturize, enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. It is compatible with natural rubber latex and polyisoprene condoms.

The device is a Class 2 Obstetrics & Gynecology product with product code NUC, cleared via the Traditional 510(k) pathway under regulation number 884.5300. It is supplied as a single-use or reusable topical gel, intended for use in intimate personal care settings, with no stated sterility or MRI safety requirements in the provided data.

AI-generated from registry data, 23 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK242958 Date20 Mar 2025ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
NUC
Device Class
Class II
Regulation
21 CFR Part 884.5300
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Other devices from Joylux, Inc.

Questions

  • What is Joylux Intimacy Gel (PG3100) intended for?

    Joylux Intimacy Gel (PG3100) is intended for penile and/or vaginal application to lubricate and moisturize, enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. It is designed for use in intimate personal care settings.

  • Is Joylux Intimacy Gel (PG3100) compatible with condoms?

    Yes, Joylux Intimacy Gel (PG3100) is compatible with natural rubber latex and polyisoprene condoms, as stated in the device description, ensuring it does not compromise condom integrity during use.

  • How is Joylux Intimacy Gel (PG3100) supplied and is it sterile?

    Joylux Intimacy Gel (PG3100) is supplied as a single-use or reusable topical gel. The provided data does not state any sterility requirements, so it is not marketed as a sterile product.

  • What regulatory pathway was used for Joylux Intimacy Gel (PG3100)?

    Joylux Intimacy Gel (PG3100) was cleared via the Traditional 510(k) pathway under regulation number 884.5300, with a decision of substantially equivalent (SESE) granted on March 20, 2025, under K-number K242958.