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Solevy Co. LLC Silicone Based Personal Lubricant

FDA 510(k)

Class II (US FDA 510(k))

510(k) K203644

by Solevy Co., LLC

Identifiers

510(k) Number
K203644 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)

A silicone-based personal lubricant designed for penile and vaginal application. It is intended to provide lubrication and moisturization to enhance comfort and ease during intimate sexual activity, supplementing natural bodily lubrication. Compatible with natural rubber latex and polyisoprene, it is classified as a personal lubricant under product code NUC.

Supplied as a single-use product, this lubricant is intended for use in obstetrics and gynecology settings. It has received FDA 510(k) clearance under the Traditional pathway and is classified as a Class II device under special controls. The device is regulated under regulation number 884.5300 and is authorized for distribution in the United States.

Frequently asked questions

What is the primary purpose of this silicone-based lubricant in clinical settings, and how does it differ from standard personal lubricants?

This silicone-based lubricant is specifically designed to provide lubrication and moisturization for penile and vaginal use during intimate sexual activity, supplementing natural bodily lubrication. It is intended for use in obstetrics and gynecology settings, where comfort and ease are critical. Unlike standard personal lubricants, it is explicitly formulated to be compatible with natural rubber latex and polyisoprene, making it suitable for use with condoms made from these materials. This ensures broader versatility in clinical and personal applications.

Is this lubricant intended for single-use only, and if so, how should it be stored to maintain its integrity?

Yes, this lubricant is supplied as a single-use product, which helps ensure hygiene and prevent contamination. To maintain its integrity, it should be stored in a cool, dry place, away from direct sunlight and extreme temperatures. Proper storage conditions are essential to preserve its silicone-based formulation and prevent degradation, ensuring optimal performance and safety for its intended use.

What regulatory pathway was followed for FDA clearance, and what does this mean for healthcare providers using this product?

This lubricant received FDA clearance through the 510(k) Traditional pathway, meaning it was determined to be substantially equivalent to a legally marketed device already on the market. It is classified as a Class II device under special controls, regulated under CFR 884.5300 for personal lubricants. For healthcare providers, this clearance indicates that the product meets FDA standards for safety and effectiveness, though it does not imply any specific clinical indication beyond its described use in obstetrics and gynecology settings.

Are there different sizes or models available for this lubricant, and how would a clinician determine the appropriate one for a patient?

The provided data does not specify distinct sizes or models for this lubricant, as it is described as a single-use product without additional packaging variations. Since it is designed for general penile and vaginal application, clinicians do not need to select a specific size or model—it is intended for universal use in these contexts. However, patients should always follow manufacturer guidelines for proper application and usage.

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: Solevy Co. LLC Silicone Based Personal Lubricant, SOLEVY CO. LLC FDA Filings - FDA.report, K203644 FDA 510(k) - Solevy Co. LLC Silicone Based Personal ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Solevy Co., LLC

Sources (1)

  • FDA 510(k) K203644 24 fields · synced Sep 18, 2026