HIFU devices from South Korea and the USA. Leading manufacturers and gold standards in aesthetic medicine. Prices

South Korea and the United States are among the countries that set the global standards for the production of HIFU devices. Companies from these countries develop innovative technologies, often combining ultrasound with other methods, and rely on clinical studies and strict safety certifications. In this article, we will look at the most popular manufacturers and their leading devices.

1. South Korea

South Korea is global leader in the aesthetic business and is a key driver of innovation in the HIFU and energy-based medical devices (EBD) market. The Korean market in 2025 is characterized by a combination of advanced devices for clinics and consumer-oriented home models. Local manufacturers are betting on multifunctionality, portability, and integration of HIFU with other technologies such as RF/EMS, while also embracing K-Beauty trends as “medical skincare.” Korean companies such as Classys Inc. have achieved unprecedented global success, with their total overseas sales exceeding KRW 100 billion in 2023.

Korean manufacturers

1. Classys Inc. / Ultraformer: Classys, founded in 2007, is a world leader that produces the leading HIFU devices Ultraformer III (Shurink) and Ultraformer MPT (Shurink Universe), the latter using the innovative MPT (Micro Pulsed Technology). Classys also manufactures the RF device Volnewmer and the HIFU body contouring device Scizer, which has received FDA approval in the US.

•Technological superiority: Ultraformer MPT is the latest, fourth generation HIFU device, which is 2.5 times faster from Ultraformer III and creates 417 micro coagulation points per line (versus 17 with Ultraformer III), which justifies the high investment.

• Consumables: Only one original cartridge for Ultraformer MPT (with 20,000 pulses, for depths 1.5 – 2.0 – 3.0 – 4.5 mm) costs €3,660.00 with VAT (or €3,000.00 excluding VAT).

2. Jeisys Medical Inc. (Manufacturer of Ultracel Q+): A Seoul-based company that develops HIFU devices like the Ultracel Q+, which help lift eyebrows and improve skin elasticity on the thighs using focused ultrasound energy in linear and spot patterns.

3. ASTERASYS Co., Ltd.: This company, based in Seoul, Korea, manufactures medical devices such as the Liftera-A, which is a High Intensity Focused Ultrasound (HIFU) product. Several sources compare the Liftera to other popular HIFU devices such as Ultraformer and Ultherapy, highlighting the benefits of Liftera, including less pain, faster recovery, and specialized pen-type applicator for treating curved and delicate areas. In a detailed description of the evolution of HIFU devices, Liftera is classified as generation advancement in this aesthetic technology. Liftera is a device from second generation HIFU technology, known for its TDT™ (Thermal Diffusion Treatment) technology, which offers less pain and faster recovery compared to older devices like Ultherapy and Ultraformer.

4. KORUST (KORea Ultra Sound Technology Co., Ltd): A specialized company in HIFU that aims to be the best in the world by developing effective HIFU transducers and owning a patented technology for manufacturing ceramics for them.

5. Eunsung Global: A company from the Republic of Korea, whose product range includes HIFU, laser systems, various types of RF technologies (Needle RF, Thermal & Fractional RF, Multi-Function RF), cryotherapy and other aesthetic care devices.

6. Hironic Co., Ltd.: This company is a well-known Korean manufacturer of aesthetic HIFU devices, as their Doublo Gold is a popular CE marked system preferred in clinics for its fast treatment time and dual line technology.

7. WONTECH Co., Ltd.: A company listed among the key players in the market that manufactures aesthetic HIFU systems.

8. Alpinion Medical Systems: A company from Korea that is a key player in the market and manufactures HIFU platforms.

9. Reziena Inc.: One of the Korean suppliers that focuses on the innovative segment of portable and home HIFU devices, offering a wireless rechargeable device for home use.

10. ITC Co., Ltd. is a South Korean manufacturer that focuses on the innovative segment of portable and home HIFU devices. Founded in 1995, the company is a manufacturer of surgical and aesthetic devices and holds CE and ISO13485 certifications. ITC Co., Ltd. operates simultaneously in the market for mass, affordable HIFU devices for home use, while maintaining a portfolio of professional medical and surgical equipment.

11. K1 Med: This Korean supplier focuses on the innovative segment of portable and home HIFU devices. The V-MAX HIFU device on K1 Med was created with long-lasting tipwho uses water circulation system for cooling, which allows it to be used no need to change consumable cartridges (cartridges), thus reduces costs for equipment.

12. Medicube (Brand): This brand offers a portable HIFU device called Age-R High Focus Shot HIFU, which is aimed at the consumer market for home use. Caution when using!

13. HSC CO.,LTD: This is one of the leading manufacturers of aesthetic medical devices, operating since 1998, which offers a wide range of HIFU products, including both intensive professional facial systems (SMART SONIC) and portable devices (ULVERIN), and works with 163 partners in 69 countries around the world.

Popular Korean HIFU machine manufacturers, model/type, price

2. United States of America (USA)

North America, with its strong presence in the HIFU market, represents the largest market share from 39% in 2024, thanks to advanced healthcare infrastructure and early adoption of innovative medical technologies. American companies are particularly strong in the segment of FDA-approved systems and are focused on both aesthetic (lifting) and therapeutic (oncology, urology) applications of HIFU.

American manufacturers

1. Ulthera (Merz Aesthetics): Ultherapy® is the only HIFU system approved by the FDA for lifting eyebrows, neck, chin and décolleté, and is considered the "gold standard" in non-surgical ultrasound lifting. The high price of Ultherapy is also due to the patented technology for real-time ultrasound visualization, which allows the practitioner to see the anatomical layers of the skin (including the SMAS layer) and direct the energy precisely – a feature that is missing from most cheaper HIFU devices

2. Softwave: This device uses the patented SUPERB™ Synchronous Ultrasound Parallel Beam technology (Synchronous ultrasonic parallel radiation)Softwave is a non-invasive, often single-session procedure that stimulates collagen, focusing on the middle dermal layer (about 1.5 mm).

3. Liposonix: Non-invasive surgical device "Liposonix" (Liposonix – HIFU) is developed and manufactured by Solta Medical Inc., USA, which is a world leader in the production of medical equipment. This is an FDA-approved HIFU system that is specifically designed for non-invasive body contouring and selective fat reduction in the abdominal area. When performing the Liposonix procedure, the average cost per patient in the US is between $150 and $300 per "zone" for one session, which usually lasts about an hour.

4. SonaCare Medical & Profound Medical: These companies are major players in the HIFU systems market, focusing primarily on therapeutic applications, with SonaCare Medical manufacturing Sonablate® 450, approved by the FDA for ablation of prostate tissue.

5. Insightec Ltd. (Manufacturer of Exablate): Although based in Israel, their MR-guided HIFU device (Exablate 2000) was the first MRgFUS system to receive FDA approval in 2009.

6. Acoustic Inc.: Founded in 2016 in Bellevue, Washington, this medical device company is developing therapeutic ultrasound platforms with novel high-element arrays, having received funding from the National Institutes of Health to develop next-generation 3D liver cancer screening and treatment

7. HistoSonics: This company develops Robotically Assisted Sonic Therapy (RAST™), based on histotripsy – a non-invasive method that uses focused sound energy to mechanically destroy tumors at the subcellular level.

8. Verasonics: The company offers software platforms Vantage, which provide flexible and precise capabilities for focused ultrasound (FUS) research and development, including targeting, tracking, and monitoring.

Table with American manufacturers, model/type, price

3. Japan

As a key market center in Asia-Pacific region Japan is main strategic goal for the global expansion of aesthetic devices. The market is characterized by high demand for non-invasive aesthetic procedures and is an important export market. Leading Korean companies such as Classys Inc. are actively expanding their presence in Japan, with the country included in Top 10 in their global markets. Classys Inc., for example, held its Insight Forum Osaka in 2023, focused on Ultraformer MPT and Volnewmer.

Japanese manufacturers

1. ADSS (ADSS Laser): ADSS is a company from Japan that focuses on the production of aesthetic HIFU systems. ADSS offers Standard Price, Pro Price and OEM/ODM Price for its 4D, 7D and 8D HIFU machines for complete face and body treatment. These price levels include free shipping for a limited time (Free Shipping For A Limited Time), the ability to add a language to the machine system, printing your company logo on the machine, color and appearance customization, as well as marketing services. To receive OEM/ODM prices, it is necessary to request an individual quote ("Get Custom Made Price").

2. SONIRE Therapeutics (Japan Affiliated): In November 2024, SONIRE Therapeutics announced that it had received Breakthrough Device Designation from the FDA for its HIFU system. Suizenji, designed to treat pancreatic cancer, the system is based on a 2017 Japanese clinical study.

Table of manufacturers from Japan, model / type, price

4. Europe & Israel

Manufacturers from Israel and Europe contribute significantly to the HIFU market, especially in the segment of high-tech medical and therapeutic systemsCompanies such as INSIGHTEC and Philips Sonalleve are focusing on MR-guided HIFU (MRgHIFU) technologies that provide real-time precision critical for treating tumors and neurological diseases. In the aesthetic sector, European manufacturers offer CE-certified systems with multi-layer processing.

Manufacturers

1. INSIGHTEC (Israel): This company is a world leader in MR-guided HIFU technology, with its systems (e.g. Exablate) using MRI to visualization and precise ablation of uterine fibroids and tumors, which ensures high safety.

2. Philips Sonalleve (Netherlands): Sonalleve offers MR-HIFU, which combines magnetic resonance imaging with volumetric heating technology for non-invasive treatment of fibroids of the uterus and palliative treatment of bone metastases.

3. Beco Medical (Spain): The company is the manufacturer of UltraLift HIFU Evo, a system that provides multi-layer HIFU treatment (1.5–13 mm) for complete face and body lifting, and is certified with the CE mark.

4. Theraclion (Europe): Manufacturer of HIFU systems specializing in non-invasive treatment of thyroid nodules and breast fibroadenomas.

You can read more about the specifics of different markets in the article: How do the HIFU markets differ in China, the US, Korea and Europe?