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2024 PIOON CE FDA Liposuction Machine 14
Reference: 1601196705469Medical Laser Equipments
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Product summary
Why Choose GoldHealth Medical?
GoldHealth Medical is a professional manufacturer of medical laser equipment, not a general electronics producer. As a Class III medical device manufacturer approved by China's SFDA (NMPA), our products meet the highest standards of safety and effectiveness. We hold certifications such as the EU’s CE Mark and US FDA 510(k) clearance, ensuring compliance with global regulatory requirements. Our devices are registered in over 40 countries, adhering to each nation’s specific medical device registration protocols.
Our manufacturing process strictly follows the ISO13485 medical device quality system, ensuring rigorous oversight from research and development to production and quality inspection. Every product undergoes third-party testing, and we provide comprehensive test reports and production records. At GoldHealth Medical, we deliver legal, compliant, safe, and effective solutions for healthcare professionals and institutions worldwide.
System Certifications
- Class III Medical Device Manufacturer certified by China’s National Medical Products Administration (NMPA)
- EU Medical CE Certification (Notified Body: TÜV SÜD, Code: 0123)
- US FDA 510(k) Clearance for medical devices
- Compliance with ISO13485 Medical Device Quality System (not ISO9001, which is non-mandatory for medical devices)
- ANVISA Certification (Brazil’s National Health Surveillance Agency)
Why Are Real Medical Devices Expensive?
- Stringent Standards: Medical laser equipment must comply with all mandatory safety and performance standards for medical devices, including laser safety protocols. These standards are verified by third-party testing agencies.
- Safety and Effectiveness: Our devices prioritize patient and user safety while ensuring clinical efficacy. Each product undergoes rigorous risk analysis and traceability throughout its lifecycle—from R&D to production and usage—to ensure controlled risks and safeguard lives.
- High-Quality Components: Every component, from switching power supplies to lasers, meets medical-grade specifications. Non-medical laser equipment does not adhere to these demanding standards, resulting in lower costs but compromised safety.
- Regulatory Compliance: Most countries prohibit the use of non-medical devices in clinical settings. Medical laser equipment undergoes extensive clinical testing before market release to guarantee long-term stability and accident-free operation.
At GoldHealth Medical, we take full responsibility for the safety and performance of our devices. If a product is unusually cheap, it likely hasn’t passed mandatory medical system inspections. Such products pose significant risks, including potential medical accidents or equipment failure, with no reliable after-sales support.
Why GoldHealth Medical Stands Out
- End-to-End Production Chain: From design and production to assembly, sales, and after-sales service, everything is handled in-house.
- Innovative Design: Our equipment features proprietary designs for both aesthetics and core systems. We never copy; innovation is at the heart of what we do.
- Customization Options: Tailor your device’s appearance, hardware, wavelength power combinations, and software to suit your needs.
- Intelligent Software: Our fully self-developed operating system ensures seamless functionality and advanced control.
Clinical Training and Support
GoldHealth Medical collaborates with a global network of distributors, doctors, and clinical professors to provide unparalleled support. We partner with academic institutions to host professional clinical training sessions multiple times a year. This ensures you receive comprehensive clinical solutions, procedural guidance, and technical expertise to enhance the success of your procedures.
Warranty and After-Sales Service
- Expected Lifespan: Minimum of 5 years, with testing available post-lifespan to confirm continued usability.
- Free Repairs: For non-human-induced damage, we cover repairs, including freight, or dispatch engineers for on-site inspections.
- Global Support: With experience in over 80 countries, our legal team assists with registration and customs clearance, minimizing risks of detention or confiscation during import.
GoldHealth Medical is committed to delivering cutting-edge, reliable, and safe medical laser equipment. Partner with us to experience unmatched quality, innovation, and support.
Shipping & Delivery FAQ
How are products prepared before shipment?
Each item is checked against the catalog record, protected with suitable packaging materials, and prepared with available product documentation for procurement review.
Can you support international delivery requests?
The support team can coordinate delivery options by destination, product type, and documentation requirements before confirming availability.
Are fragile or calibrated products handled differently?
Sensitive products are packed with additional cushioning and handling notes; calibration or compliance documents can be reviewed during the inquiry process.
How can I estimate lead time?
Lead time depends on stock status, destination, carrier availability, and any requested documentation. Contact the product team for a product-specific estimate.
Before you choose a medical product
Practical answers about product configuration, consumables, documents, quantities and support before a medical supply inquiry.
How do I confirm the right model and configuration?
Include the product reference, intended care setting and the functions or dimensions you need. Ask which accessories are included and which are optional. Images and a shared product name may cover more than one configuration, so confirm the exact version in the supplier response.
Will accessories or consumables fit my existing equipment?
Provide the equipment manufacturer, model and the relevant connector, size or part reference. Request compatibility information for the specific combination rather than relying on visual similarity. Follow the equipment and accessory manufacturers' instructions.
Which product documents can I request?
Depending on the product, useful requests may include a specification sheet, instructions for use, packaging details or available regulatory documents. State your destination market and the exact document required. A catalog listing does not establish that every model has a particular approval or certification.
Are all consumables sterile or suitable for single use?
No assumption should be made across the catalog. Check the labeling and instructions for the exact product, including whether it is supplied sterile, its stated use, expiry information and storage requirements. Ask for clarification before purchasing if these details are missing.
Can I ask about samples, pack sizes or minimum quantities?
Yes. Tell us the item reference, the quantity you want to evaluate and the quantity expected for the project. Sample availability, pack sizes and minimum purchase quantities depend on the product and must be confirmed individually.
What should I confirm for installation and ongoing use?
For equipment, ask about power supply, installation space, setup instructions, training materials, spare parts and the applicable service or warranty terms. Confirm which support is available for the selected model and destination before agreeing to a purchase.
How are price, lead time and delivery confirmed?
Send quantities, destination and required timing with your inquiry. Request a written response covering the selected configuration, packing, commercial terms and delivery estimate. Published product information is a starting point; an inquiry is not an order confirmation.
About Gold Health
Medical supplies for the way care is delivered
Explore Gold Health: medical equipment, clinical consumables and veterinary supplies for professional procurement.
Different care settings, one place to begin
A hospital department, an independent clinic, a laboratory and a veterinary practice can have very different purchasing needs. Our catalog brings equipment, instruments and everyday supplies into a browsable starting point for these different settings.
Explore by category, inspect the product images and use the listed details to build a shortlist. Availability and the exact configuration are confirmed for the selected item when you contact the team.
Look beyond the product name
A useful product choice depends on more than a headline. Dimensions, materials, model references, accessories, packaging and instructions can all affect whether an item belongs on your purchasing list.
We encourage buyers to identify these details early and ask for the product-specific information they need before making a decision.
Equipment and consumables need different questions
For equipment, ask about the supplied configuration, compatible accessories, electrical requirements and available service information. For consumables, confirm the stated intended use, pack quantity, storage conditions and any sterile or single-use labeling for that exact item.
The catalog helps organize the conversation. Product suitability and any clinical use must be assessed using the relevant manufacturer instructions and qualified professional review.
Turn a shortlist into a useful conversation
Send the product names or references together with your quantities, destination and preferred timing. If several items form one project, explain which accessories or consumables need to work together.
This gives the team a practical basis for discussing specifications, available documents, packaging and the next commercial steps. Please keep patient information and other sensitive records out of your inquiry.
Product attributes
Brand Name: GoldHealth Medical
Product Introduction:
GoldHealth Medical presents a cutting-edge Class III medical device designed for precision, safety, and versatility. Engineered with state-of-the-art technology, this device is tailored for use in hospitals, clinics, research labs, and rehabilitation centers, as well as for home healthcare. Its advanced features and biocompatibility-tested materials ensure unparalleled performance and reliability, making it an indispensable tool for medical professionals and caregivers alike.
Key Features and Specifications:
- Material: Constructed with A0 fireproof grade PC+ABS, including German Bayblend FR1514, ensuring durability and safety.
- Wavelength Options: Dual-wavelength capability with 1470nm and 980nm for optimal treatment flexibility.
- Power Output: Dual 10W power channels for enhanced precision and control.
- Aiming Beam: Equipped with a 650nm aiming beam (<2mW) for accurate targeting.
- Operating Modes: Supports both Continuous Wave (CW) and Pulsed modes, catering to diverse clinical needs.
- Fiber Compatibility: Compatible with 200µm, 400µm, and 600µm fibers featuring SMA905 connectors for seamless integration.
- Display: Industry-leading 7-inch RETINA touch display with HDR 1200p resolution for crystal-clear visualization and intuitive operation.
- Operating System: Fully self-developed OS that supports complete customization, empowering users to tailor the device to their specific requirements.
- Foot Switch: IPX6 waterproof medical pedal rigorously tested for over 500,000 cycles, ensuring long-lasting reliability in demanding environments.
- Weight: Lightweight design at 7kg (Net Weight) for easy portability and installation.
Safety and Compliance:
- Instrument Classification: Class III medical device, meeting the highest industry standards.
- Certifications: CE0123, FDA, ISO13485, and Class III Medical Devices compliance, guaranteeing safety and efficacy.
- Biocompatibility Tested: All materials are rigorously tested to ensure compatibility with human tissue, enhancing patient safety.
After-Sale Service and Support:
- Warranty: Comprehensive 5-year warranty for peace of mind.
- Remote Upgrade: Stay ahead with remote software updates to ensure your device always operates with the latest advancements.
- On-Site Inspection and Maintenance: Dedicated support team available for on-site inspections and maintenance, ensuring uninterrupted performance.
Packaging Details:
- Single Package Size: 67 x 47 x 36 cm
- Single Gross Weight: 15.000 kg
Shelf Life: 3 years
GoldHealth Medical’s commitment to innovation, quality, and user-centric design ensures that this device stands out as a reliable and future-proof solution for modern healthcare needs.
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