After months of virality on TikTok and over 20,000 pre-orders, Sunny announced 501(k) FDA Clearance on their revolutionary Sunny Cup + Applicator
Sunny, a self-care brand reinventing menstrual care, has achieved a significant milestone for their Sunny Cup + Applicator, by becoming the only menstrual cup and applicator to receive FDA 510(k) clearance. The Class II Medical Device removes the #1 barrier, keeping tampon users from switching to a more sustainable period care option that is free of potentially harmful materials. With the recent news of lead, heavy metals, and other toxic materials in leading menstrual products, the clearance could not come at a better time.
The Sunny Cup + Applicator is made of medical-grade silicone, as well as other reusable medical-grade materials. The Sunny Cup + Applicator inserts like a tampon, holds 2-5x the number of tampons, can be used for up to 12 hours at a time, and is reusable for up to one year. Receiving the clearance allows Sunny to continue innovating in the menstrual cup space.
“Menstrual cups have historically been exempt from the 510(k) process due to substantial equivalence,” Drew Jarvis, founder and CMO, said. “Because we invented the very first menstrual cup applicator, we had to kind of reprove that substantial equivalence, so we had to go through the 510(k) process, which speaks to the innovative nature of our device.”
Since their launch in 2022, Sunny has sold 20,000 units, raised $2.5 million, and secured $850k in presale orders. Looking ahead, the next big goal for Sunny is to establish a sustainable manufacturing process to keep up with the demand and orders. Their goal is to fulfill the outstanding pre-orders and re-open sales by the end of the year!
About Sunny
Sunny is a proud queer, women, and BIPOC-owned self-care brand dedicated to sustainable period care, inclusive education, and global impact initiatives. Cindy Belardo, Co-Founder and CEO, learned about the menstrual cup as an eco-friendly alternative to tampons in 2018 on a research trip to India. There, she learned about and developed a passion for ending period poverty, period taboos, and the need for honest education. Afterward, she presented her findings in a TEDx Talk that kickstarted the beginning of Sunny. Drew Jarvis, Co-Founder and CMO, first began innovating in period care after trying a menstrual cup in high school. This led her to enter and win a business idea pitch competition her senior year for her idea of a menstrual cup that is inserted like a tampon. It was by chance that the two met, but they instantly knew they were two pieces to the same puzzle. Together, they grew their passions for periods and self-care as a whole, and they launched Sunny in 2022. Since then, their patent-pending Sunny Cup + Applicator has sold across every state and territory in the United States. To learn more about investing in the future of menstrual care and education, please click here.