China’s Peninsula Medical Launches 3rd-Generation HIFU Device with Pioneering Class III NMPA Approval

China, November 3, 2025 — Peninsula Medical’s self-developed third-generation HIFU device, the “PenDa Ultra-Cannon” (Focused Ultrasound Skin Therapy System), has obtained a Class III medical device registration certificate (Registration No.: 20253092193) from China’s National Medical Products Administration (NMPA).

Approved for use in medical institutions, the system applies focused ultrasound thermal effects to subcutaneous tissue to improve skin laxity in the mid-to-lower face and submental and neck areas. It is prohibited for use around the eyes, nose, perioral region, auricles, thyroid, and carotid artery areas. The device must be operated by qualified professional physicians, and pretreatment assessment using a skin ultrasound diagnostic system is required to determine the appropriate treatment depth.

It is reported that this product is the first and only Class III ultrasonic aesthetic device currently approved for market in China by the NMPA.

The “classified regulation” of aesthetic medical devices serves as a core benchmark for evaluating product safety and compliance. According to the “Guidance on the Classification of Ultrasonic Instruments for Aesthetic Use” released for public consultation by the NMPA Standards Administration Center in November 2023, aesthetic devices using high-frequency ultrasound thermal or mechanical effects for skin rejuvenation are explicitly classified as Class III medical devices.

This represents the highest regulatory category for medical devices in China, meaning products must undergo the most stringent clinical trials, safety evaluations, and quality reviews before entering the market. Prior to this, most ultrasonic aesthetic devices were approved under Class II certificates, with some products even facing issues like “certificate-product mismatch” or “lack of clinical data,” posing potential risks to consumers.

The Class III approval of the PenDa Ultra-Cannon represents an early and comprehensive response to this tightening regulatory trend.

To secure this “industry-first” certificate, Peninsula Medical invested over four years and collaborated with 15 top-tier hospitals across China to conduct multi-center clinical trials. The trials included more than 2,000 participants with varying skin types and ages, validating the device across three core dimensions: “efficacy stability,” “long-term safety,” and “incidence of adverse reactions.”

Clinical data indicate that the PenDa Ultra-Cannon, utilizing an innovative combination of “large focal zone + ultra-pulse” technology, precisely delivers ultrasonic energy to the subcutaneous SMAS fascia, superficial fat layer, and dermis. It achieves significant skin tightening and wrinkle reduction while maintaining epidermal temperatures within a safe threshold of 38–40°C, ensuring both efficacy and safety. This quantifiable performance and data-backed safety profile represent the core value of the Class III certification, offering consumers clear assurance regarding the device’s compliance and reliability.

As a veteran in the domestic aesthetic device sector, Peninsula Medical’s breakthrough in achieving Class III certification is no accident. Since its founding in 2008, the company has centered its R&D on the integration of medicine and engineering: it tracks global cutting-edge technologies, adapting top-tier international research into actionable technical modules, while also grounding its work in clinical needs. Through a “clinical demand pool” established with 152 hospitals nationwide, physicians’ real-world experience directly informs product innovation. This “clinic-to-lab” R&D approach laid the foundation for the PenDa Ultra-Cannon’s technological advances.

For instance, to address common drawbacks of traditional HIFU devices — such as imprecise targeting and significant treatment discomfort — Peninsula’s R&D team collaborated with dermatology experts from leading medical institutions to optimize the ultrasound energy output algorithm. A dynamic temperature control system adjusts energy intensity in real time, preventing skin damage from localized overheating. Clinical data show that 80% of users report only mild warmth during treatment, with immediate recovery post-procedure and no disruption to daily activities.

Beyond technological innovation, Peninsula Medical’s extreme commitment to product quality has been crucial in securing the Class III certification. At its Shenzhen R&D center, a dedicated ultrasound energy testing apparatus — worth millions and submerged in constant-temperature water — simulates energy delivery precision across varying skin thicknesses during ongoing validation.

Amid the ongoing rise of appearance-driven consumption and increasingly stringent regulatory policies, the launch of the PenDa Ultra-Cannon responds to the growing consumer demand for safe aesthetic solutions. It also epitomizes the journey of domestic medical aesthetic devices evolving from import substitution toward global leadership. Looking ahead, as more compliant products enter the market, the medical aesthetics industry is poised to truly step into a new era — centered on technological innovation and grounded in safety.