BioGenesis Fertility Lubricant
FDA 510(k) K190872 · Good Clean Love, Inc.
Submission
- Device name
- BioGenesis Fertility Lubricant
- Applicant
- Good Clean Love, Inc.
Eugene, OR, US - Received
- April 3, 2019
- Decision date
- November 7, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PEB – Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5300
- Specialty
- Obstetrics/Gynecology
A personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This device may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms. This device is compatible with sperm, oocytes, and embryos and can be used by couples…
Other 510(k)s with product code PEB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212885 | Actively Trying Personal Lubricant Rose ScentedPEB · Traditional | CC Wellness, LLC | 02/11/2022SE |
| K212705 | Actively Trying Personal Lubricant UnfragrancePEB · Traditional | CC Wellness, LLC | 02/09/2022SE |
| K193450 | Pre-Seed Fertility LubricantPEB · Traditional | Church & Dwight Co., Inc. | 07/23/2020SE |
| K182585 | JO Actively Trying Personal LubricantPEB · Traditional | United Consortium | 04/26/2019SE |
| K162319 | BabyDance Fertility LubricantPEB · Traditional | Fairhaven Health, LLC | 04/28/2017SE |
| K141132 | Astroglide TTC Fertility Friendly Personal LubricantPEB · Traditional | Biofilm, Inc. | 01/09/2015SE |
| K131355 | Conceive PlusPEB · Traditional | Sasmar, Inc. | 11/07/2013SE |
| K072741 | Pre-Va Vaginal LubricantPEB · Traditional | Ingfertility, LLC | 07/16/2008SE |
| K051436 | Pre' Vaginal LubricantPEB · Traditional | Ingfertlity, LLC | 10/13/2006SE |
More from Ingfertlity, LLC
| 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 |
| K180136 | BioNude LubricantNUC · Traditional | 06/01/2018SE |
| K162207 | Restore Moisturizing Vaginal LubricantNUC · Traditional | 05/04/2017SE |
| K150094 | Good Clean Love Personal Lubricants Almost Naked and Natural Cinnamon VanillaNUC · Traditional | 11/19/2015SE |
Questions and answers
When was BioGenesis Fertility Lubricant cleared by the FDA?
BioGenesis Fertility Lubricant (K190872) received a 510(k) decision of Substantially Equivalent on November 7, 2019, 218 days after the submission was received.
What is the product code of K190872?
The FDA product code is PEB – Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible, a Class II (moderate risk) device regulated under 21 CFR 884.5300.