Jeisys Medical’s high-frequency medical device, POTENZA BASIC, has received partial modification approval from Japan’s Ministry of Health, Labour and Welfare. This approval expands the product’s operational scope in the Japanese market by adding new tips and handpieces to the existing lineup.
Jeisys Medical announced on Tuesday that POTENZA BASIC secured partial modification approval for medical device manufacturing and sales from the MHLW on October 13.
POTENZA BASIC initially gained medical device approval in Japan on December 5, 2023. The recent modification approval adds seven new needle tips to the officially approved items, including the motor handpiece, CP tip, S tip, and I tip.
POTENZA BASIC is a radiofrequency (RF) microneedling medical device that offers both non-invasive and invasive treatment options. Its versatile tips and handpiece configurations allow healthcare professionals to tailor treatments to specific patient needs.
This approval significantly broadens the options for Japanese medical institutions to adopt and utilize the product. The company stated that this development also paves the way for various medical facilities, including university hospitals, to consider incorporating the device into their practices.
POTENZA has secured major regulatory approvals from authorities such as the Korean Ministry of Food and Drug Safety and the U.S. Food and Drug Administration. Since its 2019 launch, the device has been distributed globally, with cumulative sales exceeding 5,500 units as of August.
A spokesperson for Jeisys Medical commented that this partial modification approval in Japan enables them to offer a wider range of tips and handpieces in the Japanese market. It aims to expand the global market presence by navigating regulatory approval processes tailored to each country’s specific requirements.
Jeisys Medical, founded in 2001, specializes in aesthetic medical devices. Following the launch of its RF device ‘IntraCell’ in 2009, the company has expanded its product portfolio to include various energy-based medical devices, such as lasers and high-intensity focused ultrasound (HIFU) systems. In 2019, Jeisys introduced the microneedle RF device POTENZA and entered into a supply agreement with U.S.-based Sinocare, marking its entry into the global market. It’s worth noting that the partnership between POTENZA and Sinocare has since concluded.
In 2023, Jeisys Medical unveiled DENSITY, a non-invasive RF medical device. The company has been actively expanding its global market presence through subsidiaries in Japan, Australia, and Vietnam.