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Lubrease Female Lubricant

by Curves Limited 510(k)

Active United States

510(k) K091298

Overview

Lubrease Female Lubricant is a personal lubricant consisting of a water-based gel (95% water). It is supplied in a single-use applicator containing 1.6ml of gel. The applicator features a locking mechanism to prevent reuse. It is intended for over-the-counter use by individuals to provide immediate lubrication for vaginal dryness and relief from intimate discomfort prior to sexual intercourse.

The device is classified as a personal lubricant (product code NUC) under Class II - Special Controls. It is supplied in a single-use applicator format and is not intended for reuse. The device received FDA 510(k) clearance on February 24, 2010, after a review period of 296 days.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK091298 Date24 Feb 2010ClearedStatusActive

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

Questions

  • What is Lubrease Female Lubricant used for?

    Lubrease Female Lubricant is a water-based personal lubricant designed to provide immediate lubrication for vaginal dryness and relief from intimate discomfort prior to sexual intercourse. It is intended for over-the-counter use by individuals.

  • How is Lubrease Female Lubricant supplied?

    Lubrease Female Lubricant is supplied in a single-use applicator containing 1.6ml of water-based gel (95% water). The applicator features a locking mechanism to prevent reuse, ensuring hygiene and safety for each application.

  • Is Lubrease Female Lubricant sterile and can it be reused?

    Lubrease Female Lubricant is supplied in a single-use applicator format and is not intended for reuse. The locking mechanism on the applicator prevents accidental reuse, which helps maintain product integrity and user safety.

  • What is the regulatory status of Lubrease Female Lubricant?

    Lubrease Female Lubricant received FDA 510(k) clearance on February 24, 2010, after a review period of 296 days. It is classified as a personal lubricant (product code NUC) under Class II - Special Controls.