【South Korea 】Shenbi: 'FDA Does Not Lie' – K-Medical Tech Exporter Reaches 96 Countries

Shenbi, a South Korean developer and manufacturer of aesthetic medical devices based on radiofrequency (RF), plasma, and ultrasound technologies, exports to 96 countries, with 80–90% of its revenue generated overseas. The company, founded in 1999, holds six U.S. FDA clearances, along with CE marking and KGMP certification. CEO Kang Sun-young stated, 'FDA does not lie. We will leverage our technological prowess and global network to become a leading K-medical tech company.' During a visit to Shenbi's headquarters in Seongdong-gu, Seoul, on April 14, assembly lines were observed producing home-care beauty devices, consumables, RF equipment, and plasma-based medical aesthetic devices. Products undergo individual output and operation checks, followed by 100% quality inspection before storage.

Kang noted that while global regulations such as the EU Medical Device Regulation (MDR) are tightening, South Korea still lacks sufficient personnel and support systems for certification. 'We have completed on-site MDR evaluations, but domestic certification response manpower shortages are prolonging the process. Once certification is fully secured, we expect 30–40% additional growth over current revenue.' Key products include the microneedle RF device 'VertuRF,' the dual plasma device 'Pladuo,' the non-invasive RF device 'Sunny,' and the next-generation non-invasive device 'Diacore.' Shenbi began FDA clinical trials in 2011 and obtained its first FDA clearance in 2016. Kang emphasized, 'FDA certification boosted our credibility in global markets. In the U.S., device utilization is broad among medical professionals and in the aesthetics market. Recently, K-beauty demand is also expanding in Brazil and other South American countries.'

Product strategies are tailored by region: VertuRF is popular in the U.S., Sunny in the Middle East, and Pladuo in Russia and Japan. Choi Min, senior manager of product clinical planning, explained, 'In the Middle East, demand for beard and scalp management is high, and Sunny can be used on hairy areas, so response is good. Japan values papers and clinical data, so we expand through academic presentations and clinical evidence.' Shenbi produces 150–200 devices per month, combining planned production with made-to-order manufacturing to handle high-volume overseas orders. Export revenue grew from KRW 29.4 billion in 2023 to KRW 31.0 billion in 2024, and is projected at KRW 33.2 billion in 2025. Total revenue rose from KRW 31.2 billion to KRW 35.1 billion and is forecast at KRW 41.2 billion.

The company is developing successors to VertuRF and Pladuo2, with some products in certification testing and new devices under development. Kang concluded, 'Over 27 years, I've learned that ideas, regulatory approvals, and technological competitiveness are most important. We take pride in growing into a company that accumulates technology and develops in-house, not just assembles devices. Our philosophy is that when the face becomes younger and healthier, the mind and body also become healthier. We will stay focused on our core business.'

Source: Read the original report | Published: May 18, 2026