Restore Moisturizing Vaginal Lubricant
FDA 510(k) K162207 · Good Clean Love
510(k) numberK162207
Submission
- Device name
- Restore Moisturizing Vaginal Lubricant
- Applicant
- Good Clean Love
Eugene, OR, US - Received
- August 5, 2016
- Decision date
- May 4, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NUC – Lubricant, Personal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5300
- Specialty
- Obstetrics/Gynecology
This device is a personal lubricant, for penile and/or 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, and/or polyurethane condoms.
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| K261905 | BUM OilNUC · Traditional | Bumlicious, LLC (DBA Bumlicious) | 08/07/2026SE |
| K261177 | PINKSLIP Water-Based Personal Lubricant and MoisturizerNUC · Traditional | Pinkslip, LLC | 07/09/2026SE |
| K261909 | Plum Vagiceuticals Vaginal Moisturizing SuppositoriesNUC · Traditional | PCCA, Inc. | 07/06/2026SE |
| K254011 | Flow Water-Based Personal LubricantNUC · Traditional | LBDO Group, Inc. | 06/22/2026SE |
| K261292 | PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant)NUC · Traditional | PR Personal Care Laboratories | 06/11/2026SE |
| K252914 | Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147)NUC · Traditional | Hathor Professional Skincare , Ltd. | 06/09/2026SE |
| K260068 | pjur NATURE Touch, 100 mlNUC · Traditional | Pjur Group Luxembourg S.A. | 05/21/2026SE |
| K254101 | Julva Velvé Water-Based Personal LubricantNUC · Traditional | Golden Isles Medical, Inc. | 04/16/2026SE |
| K260007 | Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Suppository (HA…NUC · Traditional | Hudi Pharma Srl | 04/01/2026SE |
More from Hudi Pharma Srl
| 510(k) | Device | Decision |
|---|---|---|
| K242162 | Coconut HybridNUC · Traditional | 09/19/2024SE |
| K212000 | MedleyNUC · Traditional | 11/18/2021SE |
| K211998 | Desnuda ReflectNUC · Traditional | 11/18/2021SE |
| K193448 | BioNourish LubricantNUC · Traditional | 03/12/2020SE |
| K190872 | BioGenesis Fertility LubricantPEB · Traditional | 11/07/2019SE |
| K180136 | BioNude LubricantNUC · Traditional | 06/01/2018SE |
| K150094 | Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon VanillaNUC · Traditional | 11/19/2015SE |
Questions and answers
When was Restore Moisturizing Vaginal Lubricant cleared by the FDA?
Restore Moisturizing Vaginal Lubricant (K162207) received a 510(k) decision of Substantially Equivalent on May 4, 2017, 272 days after the submission was received.
What is the product code of K162207?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.