JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant
FDA 510(k) K183384 · United Consortium
Submission
- Device name
- JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant
- Applicant
- United Consortium
Valencia, CA, US - Received
- December 6, 2018
- Decision date
- March 4, 2019
- 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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| K261177 | PINKSLIP Water-Based Personal Lubricant and MoisturizerNUC · Traditional | Pinkslip, LLC | 07/09/2026SE |
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| K254101 | Julva Velvé Water-Based Personal LubricantNUC · Traditional | Golden Isles Medical, Inc. | 04/16/2026SE |
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|---|---|---|
| K192203 | JO for Him H2O Gel Original Personal LubricantNUC · Traditional | 02/10/2020SE |
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| K191214 | JO Premium Jelly Original Personal LubricantNUC · Traditional | 08/01/2019SE |
| K182585 | JO Actively Trying Personal LubricantPEB · Traditional | 04/26/2019SE |
| K183584 | JO H2O Jelly Original Personal LubricantNUC · Traditional | 04/17/2019SE |
| K182105 | JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal…NUC · Traditional | 11/14/2018SE |
| K181408 | JO Classic Hybrid Personal LubricantNUC · Traditional | 08/27/2018SE |
| K180712 | Coconut Infused Hybrid Personal LubricantNUC · Traditional | 06/06/2018SE |
| K180219 | JO H2O Flavored Personal LubricantsNUC · Traditional | 04/20/2018SE |
| K180083 | Silicone Personal Lubricant, ALL-IN-ONENUC · Traditional | 04/09/2018SE |
Questions and answers
When was JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant cleared by the FDA?
JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant (K183384) received a 510(k) decision of Substantially Equivalent on March 4, 2019, 88 days after the submission was received.
What is the product code of K183384?
The FDA product code is NUC – Lubricant, Personal, a Class II (moderate risk) device regulated under 21 CFR 884.5300.