Actively Trying Personal Lubricant Unfragrance
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K212705 FDA 510(k)
- FDA Product Code
- PEB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.5300 FDA 510(k)
- Regulation Number
- 884.5300 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Personal Lubricant, Gamete, Fertilization, and Embryo Compatible, classified under product code PEB. It is designed to provide lubrication for penile and/or vaginal application, aiding in the ease and comfort of sexual activity while maintaining compatibility with reproductive processes.
The Actively Trying Personal Lubricant Unfragranced is supplied as a single-use product and is intended for non-medical, consumer use. It has received FDA 510(k) clearance under the Traditional pathway, with a decision date of February 9, 2022. The device falls under Class II with Special Controls and is regulated under FDA regulation number 884.5300, with an advisory committee classification in Obstetrics/Gynecology.
Frequently asked questions
Is this lubricant safe to use during fertility treatments or procedures involving gametes, fertilization, or embryos?
Yes, the Actively Trying Personal Lubricant Unfragranced is explicitly designed to be gamete, fertilization, and embryo compatible, meaning it is formulated to avoid interfering with reproductive processes. This makes it suitable for use during fertility treatments or procedures where compatibility with reproductive cells or environments is critical.
How is the Actively Trying Personal Lubricant Unfragranced supplied, and is it meant for single-use only?
The lubricant is supplied as a single-use product, meaning each application requires a new unit. This ensures hygiene and prevents cross-contamination, which is particularly important for consumer use in personal lubrication.
What sizes or models are available for the Actively Trying Personal Lubricant Unfragranced, and how do I identify them?
The device data does not specify distinct sizes or models beyond its classification as a personal lubricant. However, it is categorized under product code PEB and includes multiple registration numbers (e.g., 3040301765, 3007067755, etc.), which may correspond to different variants or packaging sizes. For precise details, refer to the manufacturer’s packaging or product labeling.
Is the Actively Trying Personal Lubricant Unfragranced sterile, and if so, how should it be stored?
The device data does not explicitly state whether the lubricant is sterile, but it is classified as a non-medical, consumer-use product. For optimal shelf life and safety, it should be stored in a cool, dry place away from direct sunlight, as recommended for most personal lubricants. Always follow the manufacturer’s storage instructions on the packaging.
What regulatory pathway was followed for FDA clearance, and what does this mean for its safety and effectiveness?
The Actively Trying Personal Lubricant Unfragranced received FDA 510(k) clearance under the Traditional pathway, meaning it was determined to be substantially equivalent to a legally marketed device already on the market. This clearance indicates that the FDA reviewed its design, materials, and intended use to ensure it meets safety and performance standards for personal lubricants, particularly those compatible with reproductive processes.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Actively Trying Personal Lubricant Unfragrance, Actively Trying Personal Lubricant Unfr... (K212705) - FDA 510 (k), Actively Trying Personal Lubricant Unfragrance — FDA K212705, Actively Trying Personal Lubricant Unfragrance… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K212705 | Class II | Active |
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Manufacturer
- Manufacturer
- CC Wellness LLC
- FDA Applicant
- CC Wellness, LLC
Sources (1)
- FDA 510(k) K212705 24 fields · synced Sep 19, 2026