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【South Korea】FDA 6-Certified 'Shenbi' Targets Global Market with K-RF Aesthetic Medical Devices

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Editor's note

This piece relies heavily on CEO Kang Sun-young’s statements and company-provided revenue data, with no independent verification. For buyers, Shenbi’s FDA-certified portfolio and 80% overseas revenue signal strong market traction, but the heavy Russia exposure (25-30%) poses a supply-chain risk amid geopolitical tensions. The regulatory question remains whether future FDA clearances will sustain growth.

Shenbi, a specialized radiofrequency (RF)-based aesthetic medical device company, is leveraging its FDA-certified technology to emerge as a global medical tech firm.

Founded in 1999, Shenbi develops and manufactures microneedle RF device 'Virtue RF', dual plasma device 'Pladuo', and non-invasive RF device 'Sunny'. The company's strength lies in handling R&D, production, manufacturing, and sales in-house.

Shenbi currently exports to 96 countries, including the US, Russia, the Middle East, and South America, with over 80% of total revenue coming from overseas markets. Russia accounts for the largest share at 25-30%, followed by the US at about 15%.

Since its skin aesthetic device 'Vivace' received FDA approval in 2016, the company has accelerated global expansion. Subsequently, six products—Virtue RF, Pladuo, Sunny, AF Laser, and Diacore—have obtained FDA certification.

At a recent InnoBiz PR Day, Shenbi CEO Kang Sun-young presented the company's key business and overseas expansion trends.

Based on FDA certifications, Shenbi's revenue has grown rapidly: from KRW 31.3 billion in 2023 to KRW 35.2 billion in 2024, and KRW 41.2 billion last year. In 2023, the company won the '$20 Million Export Tower' award and is now pursuing the '$30 Million Export Tower'.

Its flagship product, Virtue RF, is an RF device used for collagen regeneration and improving pores and wrinkles, accounting for over half of total export value last year. Pladuo, the world's first dual plasma technology-based device, is used for skin treatment, acne, and rosacea improvement.

Recently, Shenbi has accelerated its push into the Middle East and Brazil. The company noted that the non-invasive RF device 'Sunny' is gaining attention in the Middle East due to high demand for beard treatments, while in Brazil, the K-beauty trend is driving growing interest among local medical professionals.

"Skin aesthetic devices ultimately compete on technology and ideas," said Kang Sun-young, CEO of Shenbi. "All six FDA-certified devices have secured SCI-level papers, and we aim to grow into a global medical tech company through technological advancement." She added, "Shenbi is not just a device manufacturer but a technology-accumulating company. We will continue R&D investment and talent acquisition to promote 'Made in Korea' technological competitiveness worldwide."

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