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Vaginal Moisturizing Gel

by Combe Incorporated United States 510(k)

510(k) K150615

Product code NUC

Overview

This device is classified as a Personal Lubricant (NUC product code) and is designed to moisturize and lubricate the vaginal area. It supplements natural body lubrication to enhance comfort and ease during intimate sexual activity, providing relief from dryness and irritation. The formulation is intended for both vaginal and penile application, ensuring versatility in use.

The Vaginal Moisturizing Gel is supplied as a pre-filled applicator for convenient application. It is intended for single-use and is compatible with natural rubber latex and polyisoprene condoms. The device holds an FDA 510(k) clearance (K150615) under the Obstetrics/Gynecology advisory committee, classified as Class II under regulation number 884.5300. No third-party review was required for this submission.

Summary written by AI from registry data, 1 Oct 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK150615 Date1 May 2015ClearedStatusActive

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 America
  • Active
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

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

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Questions

  • What is the Vaginal Moisturizing Gel used for?

    The Vaginal Moisturizing Gel is a personal lubricant intended to supplement natural body lubrication. It helps moisturize and lubricate the vaginal area to enhance comfort and ease during intimate sexual activity, providing relief from dryness and irritation. Its formulation is also suitable for penile application, making it versatile for shared use.

  • How is the Vaginal Moisturizing Gel supplied?

    This device comes as a pre-filled applicator, which ensures convenient and precise application. Each applicator is designed for single-use, eliminating the need for refilling or reuse.

  • Is the Vaginal Moisturizing Gel compatible with condoms?

    Yes, the gel is specifically formulated to be compatible with natural rubber latex and polyisoprene condoms. This ensures safe and effective use without compromising condom integrity.

  • Is the Vaginal Moisturizing Gel reusable or single-use?

    The Vaginal Moisturizing Gel is intended for single-use only. Each pre-filled applicator is designed to be used once, promoting hygiene and reducing the risk of contamination.

  • What regulatory clearance does the Vaginal Moisturizing Gel hold?

    The device holds an FDA 510(k) clearance (K150615) under the Obstetrics/Gynecology advisory committee, classified as Class II under regulation number 884.5300. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K150615 24 fields · synced 22 Oct 2026