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Help CenterFDA Cleared 12D Max Hifu Device for Vaginal Rejuvenation and Skin Tightening
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Solana (Guangzhou) Beauty Technology Co., Ltd. is proud to present the FDA Cleared 12D Max HIFU Device for Vaginal Rejuvenation and Skin Tightening. As a dedicated manufacturer based in Guangzhou, China, with an annual export value exceeding US$50 million, we combine advanced technology with rigorous quality control to deliver professional-grade aesthetic solutions. This device is engineered to address both intimate wellness and facial/body contouring, offering a non-invasive alternative that prioritizes patient comfort and visible results. With ISO9001 certification and a growing presence in markets across North America, Europe, and Asia, our HIFU device represents a reliable investment for clinics and spas seeking to expand their service portfolio.
The 12D Max HIFU system utilizes high-intensity focused ultrasound energy to penetrate deep into the skin's layers, stimulating collagen production and tissue tightening. Unlike traditional surgical methods, this device requires no downtime and delivers gradual, natural-looking improvements. Whether used for vaginal rejuvenation to address laxity or for facial skin tightening to reduce wrinkles, the device offers versatile treatment options with customizable energy levels. Our team of 5-10 skilled professionals ensures each unit meets strict manufacturing standards, backed by responsive after-sales support.
Key Features and Technical Specifications
- FDA Cleared Technology: The device has received FDA clearance, indicating it meets stringent safety and efficacy requirements for non-invasive aesthetic procedures.
- 12D Max Cartridge System: Features advanced cartridges with multiple depths (1.5mm, 3.0mm, 4.5mm, and 13.0mm) to target different tissue layers for optimal results.
- Dual Application: Specifically designed for both vaginal rejuvenation (using a dedicated handpiece) and facial/body skin tightening.
- Real-Time Energy Monitoring: Built-in sensors ensure consistent energy delivery and protect against overheating, enhancing patient safety.
- User-Friendly Interface: Touchscreen control panel with preset treatment protocols for easy operation by trained professionals.
- Portable Design: Compact footprint (approx. 40x30x25 cm) suitable for small treatment rooms or mobile clinics.
- Energy Output: Adjustable from 0.5 to 3.0 Joules per pulse, with pulse repetition rate up to 10 Hz.
| Parameter | Specification |
|---|---|
| Technology | High-Intensity Focused Ultrasound (HIFU) |
| Cartridge Depths | 1.5mm, 3.0mm, 4.5mm, 13.0mm |
| Treatment Areas | Face, neck, décolletage, abdomen, thighs, vaginal area |
| Energy Range | 0.5 – 3.0 Joules |
| Pulse Repetition Rate | Up to 10 Hz |
| Display | 10-inch color touchscreen |
| Power Input | AC 110-240V, 50/60Hz |
| Weight | Approximately 12 kg |
Benefits for Your Practice
- Expand Service Offerings: Add non-invasive vaginal rejuvenation and skin tightening to your menu, attracting a broader client base seeking intimate wellness and anti-aging solutions.
- High Return on Investment: With minimal consumable costs (only cartridges), the device offers a quick payback period—typically within 3-6 months for busy clinics.
- Patient Satisfaction: Clients appreciate the lack of downtime, gradual natural results, and improved confidence. Many report noticeable tightening after just 1-2 sessions.
- Safety and Compliance: FDA clearance and ISO9001 certification provide peace of mind for both practitioners and patients, reducing liability risks.
- Easy Training: The intuitive interface and preset protocols allow new users to become proficient within a few days, minimizing training time.
Why Choose Solana?
Since our establishment in 2020, Solana (Guangzhou) Beauty Technology Co., Ltd. has grown rapidly, achieving an annual export value between US$50 million and US$100 million. Our factory, though compact at under 1,000 square meters, operates with precision and efficiency, producing devices that meet international standards. We serve markets across North America, South America, Eastern Europe, Southeast Asia, and beyond, with a dedicated team of 5-10 professionals who oversee every step from assembly to quality testing. Our ISO9001 certification reflects our commitment to consistent quality, and we offer comprehensive after-sales support including technical training, spare parts availability, and a standard 1-year warranty. By choosing our FDA Cleared 12D Max HIFU Device, you are partnering with a manufacturer that prioritizes innovation, reliability, and customer success.
Ready to elevate your practice? Contact us today for a quotation, sample testing, or to discuss customization options. Our team is available to answer your questions and provide detailed product documentation. Invest in the Solana difference and offer your clients the advanced, non-invasive treatments they deserve.
Frequently Asked Questions (FAQ)
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Q: Is the FDA clearance for the entire device or just specific cartridges?
A: The FDA clearance applies to the 12D Max HIFU device system, including its standard cartridges used for skin tightening and vaginal rejuvenation. We recommend reviewing the specific clearance letter for detailed scope. -
Q: How many treatment sessions are typically needed for vaginal rejuvenation?
A: Most patients see optimal results after 2-3 sessions, spaced 4-6 weeks apart. However, individual results may vary based on age, tissue condition, and desired outcomes. -
Q: What is the shelf life of the cartridges?
A: Cartridges have a shelf life of 2 years when stored in a cool, dry place away from direct sunlight. Each cartridge is sealed and sterile until opened. -
Q: Can the device be used on all skin types?
A: Yes, HIFU technology is safe for all skin types (Fitzpatrick I-VI) because it targets deeper tissue layers without affecting the epidermis. However, a patch test is recommended for first-time users. -
Q: What kind of training do you provide?
A: We offer online training manuals, video tutorials, and optional on-site training for bulk orders. Our technical support team is available via email and video call for troubleshooting. -
Q: Is the device portable for mobile clinics?
A: Yes, the device weighs approximately 12 kg and has a compact design, making it suitable for mobile or home-service setups. It operates on standard voltage (110-240V). -
Q: What is your warranty policy?
A: We provide a 1-year warranty covering manufacturing defects. Extended warranty plans are available upon request. Spare parts are stocked for quick replacement. -
Q: Can I get a sample unit for testing before bulk purchase?
A: Yes, sample orders are welcome. We offer a demo unit at a discounted price, with the cost deductible from future bulk orders. Contact our sales team for details.
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