Personal Lubricant Ring
The Personal Lubricant Ring is an obstetrics/gynecology device in the form of a ring designed for vaginal application to moisturize and lubricate, enhancing the ease and comfort of intimate sexual activity and supplementing the body's natural lubrication. It may or may not be compatible with various types of condoms. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 884.5300 in the Obstetrics/Gynecology specialty. It carries product code QPD and is not an implant and not life-sustaining.
Basic Information
- Product Code
- QPD
- Device Class
- FDA class 2
- Regulation Number
- 884.5300
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 1
Device Characteristics
Definition
This device is a personal lubricant, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, polyurethane, and/or internal condoms.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K203377 | VR101 Lubricating Intravaginal Ring | May 20, 2021 | Substantially Equivalent | J3 Bioscience, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.