Gun Oil, Pink, Gun Oil H2O, Pink Water
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K152918 FDA 510(k)
- FDA Product Code
- NUC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.5300 FDA 510(k)
- Regulation Number
- 884.5300 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Gun Oil, Pink, Gun Oil H2O, and Pink Water are personal lubricants. These devices are intended to provide lubrication during sexual activity.
This device is regulated under FDA 510(k) clearance as a Class 2 medical device. It is categorized under the Obstetrics/Gynecology medical specialty.
Frequently asked questions
What is the intended use of these lubricants?
Gun Oil, Pink, Gun Oil H2O, and Pink Water are personal lubricants intended to provide lubrication during sexual activity.
How are these devices regulated?
These devices are regulated under FDA 510(k) clearance as Class 2 medical devices within the Obstetrics/Gynecology medical specialty.
Who is the manufacturer of these products?
These personal lubricants are manufactured by Empowered Products, Inc., located in Las Vegas, Nevada.
This description and any FAQs above were generated automatically from registry data 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. Sources consulted: PINK ® Water - GUN OIL® EU, Empowered Products Gun Oil H20 - FWB Pleasure Shop, Gun Oil H2o - manvitalcare.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152918 | Class II | Active |
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Manufacturer
- Manufacturer
- Empowered Products, Inc.
Sources (1)
- FDA 510(k) K152918 24 fields · synced Oct 6, 2026