Who We Are
Instituted in 2003, CC Wellness believes that intimate health and wellness should be accessible and stress free. Backed by consumer research, our hands-on approach to customer satisfaction has allowed CC Wellness to become a leading manufacturer and innovator of wellness products. With nineteen FDA 510(k) clearances and product profiles spanning cosmetics, OTC products and Class II medical devices, we empower consumers to fully immerse themselves into their wellness journey.
Operating in Valencia, California, all liquid formulations are developed, registered and produced in-house. Using USDA approved organic products, our company maintains CCOF certifications. Consistently achieving top 3 brand positions on Amazon, CC Wellness is recognized for delivering on its promise to produce high quality products in a socially and environmentally conscious manner. Through innovation and an entrepreneurial spirit, CC Wellness continues redefining intimacy by providing tangible solutions.
510(k) What is it?
A 510(k) or Pre-market notification is a technical document required by the Food and Drug Administration to sell medium-risk medical devices in the United States. Comprised of technical, performance, and safety records, a 510(k) must demonstrate that the device in question maintains standards set by previously approved products of similar functionality. Personal lubricants are classified as Class II medical devices meaning that they must obtain FDA clearance in order to be sold. Because personal lubricants come in prolonged contact with users topically or orally, a 510(k) establishes important factors like biocompatibility and overall safety.
A 510(k) number is required for Class II medical devices in the US.
Class II medical devices pose a higher risk of use because they are coming into sustained contact with a user, and in our case are being used internally. Therefore, the FDA must ultimately declare this product is generally safe and effective.
A 510(k) establishes which condom material the lube is compatible with, ensuring safe use with various condom materials.
A 510(k) establishes biocompatibility, which includes tests for vaginal irritation, penile irritation, and product stability testing.