Satisfaite

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K190752

by Femmepharma Consumer Healthcare, LLC

Identity

Trade Name: Satisfaite FDA UDI
Generic Name: Sexual lubricant FDA UDI
Device Name: Satisfaite vaginal moisturizer and personal lubricant is a non-sterile, water-based, white to off-white, non-irritating, non-greasy, non-staining low volume gel delivered in a single use disposable applicator for vaginal dryness. The applicator provides convenience and provides for less mess during application. Satisfaite is intended for ongoing use, not exclusively for use during intimate sexual activity. Satisfaite contains ingredients commonly used in other products for intravaginal use sold as medical devices and cosmetics. All ingredients used are approved high quality pharmaceutical grade, and considered "generally recognized as safe for their intended use" by the FDA. The quantitative formulation is considered confidential commercial information. FDA UDI
Model / Reference: 01 FDA UDI
Description: Satisfaite vaginal moisturizer and personal lubricant is a non-sterile, water-based, white to off-white, non-irritating, non-greasy, non-staining low volume gel delivered in a single use disposable applicator for vaginal dryness. The applicator provides convenience and provides for less mess during application. Satisfaite is intended for ongoing use, not exclusively for use during intimate sexual activity. Satisfaite contains ingredients commonly used in other products for intravaginal use sold as medical devices and cosmetics. All ingredients used are approved high quality pharmaceutical grade, and considered "generally recognized as safe for their intended use" by the FDA. The quantitative formulation is considered confidential commercial information. FDA UDI

Identifiers

Catalog Number: 01 FDA UDI
Primary DI / UDI-DI: 00860000221511 FDA UDI
510(k) Number: K190752 FDA 510(k)FDA UDI
FDA Product Code: NUC FDA 510(k)FDA UDI
GMDN Term: Sexual lubricant FDA UDI

Classification

Device Class: Class II FDA 510(k)FDA UDI
Legislation / Framework: 21 CFR Part 884.5300 FDA 510(k)
Regulation Number: 884.5300 FDA 510(k)FDA UDI
Advisory Committee: Obstetrics/Gynecology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

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Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Satisfaite by Femmepharma Consumer Healthcare, LLC — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K190752	Class II	Active

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Manufacturer

Manufacturer: Femmepharma Consumer Healthcare, LLC

Sources (2)

FDA 510(k) K190752 24 fields · synced Jun 18, 2026
FDA UDI 4372b597-2d66-4224-871d-93838fbbd176 35 fields · synced May 26, 2026