Top 10 HIFU Machine Manufacturers in South Korea

South Korea exported roughly US$941 million of aesthetic medical devices in 2023, according to Korea Customs Service data reported by Korean trade media — a record driven largely by lifting and energy-based platforms, and by a domestic market where Korea Customs and industry analysts note lifting devices such as HIFU lead clinic equipment demand. In HIFU specifically — high-intensity focused ultrasound, known in Korean clinics as “lifting” — one company holds around 55% of the domestic market: Classys, maker of Shurink, whose flagship Ultraformer line is sold in more than 70 countries and credited with millions of treatments per year. Behind Classys stands a deep bench of KOSDAQ-listed specialists — Hironic, Jeisys, WON TECH, Asterasys, ViOL — plus focused HIFU houses such as KORUST that supply cartridges, transducers and OEM designs worldwide. Korean machines compete aggressively on multi-line cartridges, treatment speed and price-performance, which is exactly why buyers need to distinguish genuine manufacturers from assemblers before wiring a deposit. Here are the 10 firms that define Korean HIFU manufacturing in 2026.

How We Ranked the Top Korean HIFU Machine Manufacturers

We evaluated each company on five criteria:

1. Product-line fit — HIFU and focused ultrasound must be a core business line, not a side catalog entry.
2. Technical differentiation — Proprietary transducer designs, multi-depth cartridges, linear or curved applicators, and hybrid energy combinations.
3. Regulatory standing — MFDS (Korea Ministry of Food and Drug Safety) clearances as the baseline, plus international approvals such as US FDA, CE, TGA (Australia) or Indonesia MoH.
4. Clinical and academic footprint — Published studies, university collaborations and documented treatment volumes.
5. Global distribution and service — Export track record, distributor networks and parts availability outside Korea.

Companies are grouped into tiers by scale and export maturity; positions within tiers do not imply a quality ranking. The list is informational, based on companies’ official websites, regulator databases and trade press as of October 2026; it is not a purchase endorsement. LEIJEX is a China-based manufacturer of energy-based aesthetic devices and is not ranked in this list.

1. Classys — Tier 1

Classys, listed on KOSDAQ (214150) and headquartered in Seoul, is the undisputed market leader in Korean non-invasive lifting: its Shurink device — sold internationally as Ultraformer III and Ultraformer MPT — is credited with roughly 55% of the Korean HIFU market and millions of treatments worldwide. The company’s portfolio also spans the Awtars lifting platform and dermal filler lines, and in October 2026 it announced the US launch of Shurink Home, a consumer version of its lifting technology.

Official website: https://classys.com — Visit website ↗

YouTube: CLASSYS

2. Hironic — Tier 1

Hironic, founded in 2006 and listed on KOSDAQ, was among the first Korean companies to patent focused-ultrasound lifting technology. Its Doublo line — including Doublo-S and New Doublo 2.0, the latter combining HIFU with RF microneedling — has been exported worldwide and holds Australia TGA approval, and the company extends the brand into home care with Homethera. Hironic also manufactures RF platforms such as SILKRO and the CRYO MICOOL-S cooling-assist system.

Official website: https://hironic.com — Visit website ↗

YouTube: HIRONIC

3. Jeisys Medical — Tier 2

Jeisys Medical, another Seoul-headquartered KOSDAQ company, describes itself as a global K-beauty medical device leader, with a portfolio that goes beyond HIFU into RF and laser systems. Its Ultra Z platform delivers linear and dot-mode focused ultrasound for face and body lifting, while Density (sequential monopolar + bipolar RF) and IntraCel (RF microneedling) round out a multi-energy lineup popular with Korean dermatology chains and international distributors alike. The LinearZ laser is approved by Korea’s MFDS for multi-layer skin treatment.

Official website: https://www.jeisys.com — Visit website ↗

YouTube: Jeisys Medical

4. WON TECH — Tier 2

WON TECH, founded in 1999 in Daejeon and traded on KOSDAQ, is one of Korea’s most diversified energy-device exporters. Its Liftera and Liftera V systems bring vacuum-assisted, linear HIFU lifting to clinics across Asia, Europe and the Americas through WONTECH USA and other regional arms, while Picocare (picosecond) and Pastelle (pigment laser) cover the laser side. The OLIGIO X RF collagen-stimulator line extends the portfolio into biostimulatory treatments.

Official website: https://wtlaser-en.com — Visit website ↗

YouTube: WONTECH (Oligio)

5. Asterasys — Tier 2

Asterasys, listed on KOSDAQ (450950) in January 2025, has grown quickly on the strength of two brands: Coolsoniq and Revlax in HIFU lifting, and Coolfase, a monopolar RF tightening device with tip-integrated contact cooling. The company’s HIFU exports earned it a $10 Million Export Tower award in December 2024, and in October 2025 Coolfase received US FDA clearance — a milestone few Korean RF startups have reached. Asterasys is a regular, high-visibility exhibitor at KIMES in Seoul.

Official website: https://asterasys.com — Visit website ↗

YouTube: ASTERASYS

6. ViOL — Tier 2

ViOL, listed on KOSDAQ in 2020, built its name on RF microneedling — Sylfirm X is the world’s first dual-wave (pulsed + continuous) RF microneedling system with FDA clearance and was the first such device approved in Korea for melasma treatment. The company then carried that clinical credibility into focused ultrasound: DUOTITE, launched in Japan in late 2024, targets the SMAS layer and dermis simultaneously in a single shot, and has since added Taiwan TFDA approval for face and body applications.

Official website: https://violmedical.com — Visit website ↗

7. KORUST — Tier 3

KORUST — short for KORea Ultra Sound Technology — has specialized in HIFU since its founding in 2011 and is credited as the first Korean company to commercialize focused ultrasound for dermatology. Its UTIMS line (UTIMS A3, UTIMS A3 PLUS, UTIMS MINI) covers face lifting, body lifting and contouring, with CENTERLESS cartridges designed for stable focal points, and the Celleon and CRUISE systems extend the ultrasound portfolio. MFDS certification came early, and exports span Asia, Europe and Latin America.

Official website: https://www.korust.com — Visit website ↗

YouTube: Korust

8. Tentech — Tier 3

Tentech, a Seoul-based aesthetic equipment company selected as a 2026 Hi-Seoul enterprise by the Seoul Metropolitan Government, has scaled rapidly on its Tensela two-line HIFU platform, which passed 500 cumulative domestic units sold and earned Indonesia MoH certification in March 2024. In August 2025 the company added 10TRIPLE, a three-line HIFU system cleared by Korea’s MFDS, and its Tenserma platform extends the ultrasound franchise. The product pages live at dedicated brand domains (10thera.co.kr, 10triple.co.kr).

Official website: https://tenlaser.co.kr — Visit website ↗

YouTube: Tentech Inc.

9. Newpong — Tier 3

Newpong has specialized in ultrasound-based medical and aesthetic devices since its founding, with a portfolio spanning therapeutic ultrasound, ultrasound-assisted liposuction (Liposound) and HIFU lifting. Its SONOQUEEN system delivers focused ultrasound for face and body tightening, and LINCURVE PRO — announced with Korea MFDS approval in September 2025 and marketed as the world’s first curved HIFU applicator — conforms to facial contours for faster full-face sessions. Huons Meditech signed a distribution agreement for LINCURVE PRO in late 2025, a signal of institutional confidence.

Official website: https://www.newpong.com — Visit website ↗

YouTube: Newpong

10. BNC (BTB Korea) — Tier 3

BNC, listed on KOSDAQ (256840) and part of the BTB Korea group founded in 1999, rounds out the list as the consumer-facing arm of Korean HIFU engineering. The group develops laser and HIFU medical devices alongside bio-health products, and in June 2025 launched the premium home beauty brand I.st Lucenia — anchored by the Lucenia High-Fit, which combines unlimited-use HIFU with LDM, RF and electroporation technologies. For B2B buyers it represents the home-device segment that Korean manufacturers increasingly pair with clinical lines.

Official website: https://btbkorea.kr — Visit website ↗

How to Choose a HIFU Machine Partner in South Korea

Korea’s strength in HIFU is real, but so is the counterfeit problem: third-party clinic guides estimate that a large share of “Korean-style” HIFU machines sold internationally are unlicensed copies or Chinese assemblages wearing Korean branding. Start with the regulator. Every genuine professional HIFU device in Korea holds an MFDS product license, and the Ministry of Food and Drug Safety (mfds.go.kr) publishes approval data you can cross-check — the device name, the licensed manufacturer and the approved indications should all match your quotation. Ask the supplier for the MFDS license number in writing and verify it before discussing price.

Second, look past the machine to the consumables economics. Korean HIFU platforms are cartridge-driven; cartridge price, shot counts, genuine-part verification (QR or serial authentication) and guaranteed supply length determine your cost per treatment far more than the capital price. A manufacturer that cannot document a cartridge pipeline in your country is a risk regardless of how attractive the demo was at KIMES.

Third, weigh the tier against your market. Tier 1 brands (Classys, Hironic) bring instant patient recognition and premium pricing; Tier 2 exporters (Jeisys, WON TECH, Asterasys, ViOL) balance price and feature depth; Tier 3 specialists can be excellent value if you verify licensing and parts support. Whatever you choose, run our supplier-verification checklist before signing — and if you want to benchmark laser-based alternatives against focused ultrasound, our guide to Israeli aesthetic laser companies covers the technology’s original innovators.

Frequently Asked Questions