Sunny menstrual cup and applicator secures FDA clearance
The reusable period cup inserts like a tampon
After months of virality on TikTok and over 20,000 pre-orders, period care brand Sunny has achieved a significant milestone for its Sunny Cup + Applicator, by becoming the only menstrual cup and applicator to receive FDA 510(k) clearance.
The Class II Medical Device status come in the wake of recent alarming headlines about metals found in tampons and increased interest in alternatives.
The Sunny Cup + Applicator is a reusable period cup that inserts like a tampon. It is made of medical-grade silicone, as well as other reusable medical-grade materials. It holds 2-5x the amount 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.
Drew Jarvis, founder and CMO, said:
“Menstrual cups have historically been exempt from the 510(k) process due to substantial equivalence.”
“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.”
Going viral on TikTok
Since their launch in 2022, Sunny has sold 20,000 units, raised $2.5 million, and secured $850k in presale orders.
Contributing to this has been the enormous success of the brands TikTok channel, with videos regularly securing millions of views and generating thousands of pre-orders.
“After going viral in 2022, we blew up in a way we never anticipated,” said Drew.
“We knew we had a really revolutionary product, but people's excitement over our period cup applicator exceeded our expectations, now making us the second-largest period care brand on TikTok.”
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.
The patent-pending Sunny Cup + Applicator has sold across every state and territory in the United States.