Actively Trying Personal Lubricant Rose Scented
FDA 510(k) K212885 · CC Wellness, LLC
Submission
- Device name
- Actively Trying Personal Lubricant Rose Scented
- Applicant
- CC Wellness, LLC
Valencia, CA, US - Received
- September 10, 2021
- Decision date
- February 11, 2022
- 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 |
|---|---|---|---|
| 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 |
| K190872 | BioGenesis Fertility LubricantPEB · Traditional | Good Clean Love, Inc. | 11/07/2019SE |
| 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 |
|---|---|---|
| K232091 | JO Coconut Hybrid Cooling Personal LubricantNUC · Traditional | 10/22/2023SE |
| K232090 | JO Coconut Hybrid Warming Personal LubricantNUC · Traditional | 10/11/2023SE |
| K230674 | JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant…NUC · Traditional | 05/08/2023SE |
| K221908 | JO CUMPLAY Personal LubricantNUC · Traditional | 09/20/2022SE |
| K212705 | Actively Trying Personal Lubricant UnfragrancePEB · Traditional | 02/09/2022SE |
| K210986 | H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife…NUC · Traditional | 06/10/2021SE |
| K210972 | H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for…NUC · Traditional | 06/10/2021SE |
| K200894 | Agape Cooling Personal LubricantNUC · Traditional | 07/02/2020SE |
| K200602 | Premium Cooling Personal Lubricant, Premium Anal Cooling LubricantNUC · Traditional | 06/03/2020SE |
| K200457 | Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One WarmingNUC · Traditional | 05/22/2020SE |
Questions and answers
When was Actively Trying Personal Lubricant Rose Scented cleared by the FDA?
Actively Trying Personal Lubricant Rose Scented (K212885) received a 510(k) decision of Substantially Equivalent on February 11, 2022, 154 days after the submission was received.
What is the product code of K212885?
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.