Callaly, a period care manufacturer, has received 510(k) clearance from the Food and Drug Administration (FDA) for its Callaly Tampliner.
The device is a period care product, and the first significant design improvement to the tampon in 90 years. The Tampliner, which is designed and manufactured in the UK and launched in February 2020, was invented by Dr Alex Hooi, a senior British gynaecologist and Fellow of the Royal College of Obstetricians and Gynaecologists and developed by garment technologist Ewa Radziwon, who trained at London College of Fashion.
The product is protected by four granted patent families covering 80% of the $34 billion global market. It is now being exported across Europe to Sweden, the Netherlands and Ireland.
Callaly’s multiple-award winning Tampliner was recently recognised as a “next-gen tampon” in TIME’s 100 Best Inventions of 2020 - its annual list of the 100 Best Inventions that are making the world better, smarter and even a bit more fun.
Callaly’s founder and CEO, Thang Vo-Ta said: “We are excited that Callaly was able to receive 510K clearance from the US Food and Drug Administration, opening up the important US market for our Tampliner, now earmarked for launch in Summer 2021. We are committed to delivering innovative period care products that truly meet the needs of people with periods, through dedicated innovations that are highly differentiated and adhere to the highest possible standards.”
