PIOON Lipo наконечник Pro

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Поставщик: Wuhan Pioon Technology Co. Ltd.Wuhan Ltd.

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PIOON Lipo Handpiece Pro

Lipo Handpiece Pro
It is possible to use different cannulas depending on the area, which is going to be treated.
Include 5 pieces cannula
Suitable for 600μm fiber
Length: 100mm,150mm,200mm,250mm,300mm

FAQ

Why choose PIOON

We are a professional manufacturer of medical laser equipment, not a general electronic product manufacturer. We are a Class III medical device manufacturer approved by China's SFDA. Our products have obtained the EU's CE certification for medical products and the US Food and Drug Administration (FDA)'s medical device product certification. We have registered in more than 40 countries around the world in accordance with the country's registration requirements for medical devices. Our production and manufacturing are strictly in compliance with China's medical device quality management system and ISO13485 medical device quality system. Our products have undergone strict system supervision from research and development, procurement, production, quality inspection, etc. All products must be tested by a third-party medical device testing agency, and we can provide complete test reports and records of the entire production process. We provide users with legal, compliant, safe and effective products.

What system certification does PIOON have?

* Class III medical device manufacturers reviewed and certified by the China National Food and Drug Administration (NMPA) (production license number)

* EU medical product CE certification (the notified body is Germany's South Germany, the notified body code is 0123), the CE certification must be followed by the certification body number, otherwise it is invalid certification

* US Food and Drug Administration (FDA) medical device product certification (510K)

* Manufacturing is strictly in accordance with the Chinese medical device quality management system and ISO13485 medical device quality system, not ISO9001, 9001 is not a mandatory management system

* Brazil ANVISA (Agência N.acional de Vigilância Sanitária)

Why are real medical devices expensive? (Laser equipment ≠ medical laser equipment)

1. Medical laser equipment must first be a medical device, and must strictly comply with all standard requirements and system requirements for medical equipment, and then laser safety standards. All mandatory standards must be tested by a third-party testing agency.

2. Medical laser equipment must first meet safety and effectiveness, ensure the safety of patients and users, and ensure the effectiveness of related clinical applications. Medical laser equipment must undergo product risk analysis and traceability throughout the entire process from research and development to production and use to ensure that the expected risks of the product are controllable and ensure life safety. Ordinary laser equipment does not meet these requirements and cannot guarantee these risks.

3. The standards and requirements for all components and materials of medical equipment are very clear. Key components such as switching power supplies, emergency stop switches, key switches, lasers, etc. must comply with medical standards. General laser equipment does not need to meet these demanding standards, so the cost is much lower.

4. Almost no country's regulations allow non-medical equipment products to be used in clinical applications. Therefore, ordinary laser equipment, as non-medical equipment, is essentially different from medical laser equipment.
As mentioned above, PIOON sells medical equipment, not electronic products. Medical equipment must be responsible for the safety of patients, and all components of the equipment must be produced and tested in strict compliance with relevant requirements. And it can only be put on the market after passing long-term clinical tests, so as to ensure that the equipment is safe and effective during the operation without medical accidents, and the equipment can also operate stably for a long time. And our team will serve you throughout the pre-sales and after-sales process. If there are any quality problems or medical accidents, we are fully responsible! If the product is too cheap, it must be an electronic product that has not passed the inspection of various medical mandatory systems. Once a medical accident occurs or the equipment fails, their profits are not even enough for the round-trip shipping. Do you believe that they have after-sales service?

PIOON is a manufacturer, not a middleman

Our products have a full industrial supply chain and production chain. Design-production-assembly-sales-after-sales are all completed by PIOON. The appearance and core system of our equipment are all independently innovative designs, and we never copy. All electronic components of the equipment are produced and inspected in accordance with the mandatory standards for medical devices, and relevant test reports can be provided. The software is a fully self-developed intelligent operating system. In addition, our equipment supports any customization you want from the appearance, hardware, wavelength power combination, and software

Clinical training and support

We have a large number of distributors, doctors and clinical professors around the world, and we maintain close communication with them. We also cooperate with academic institutions to hold professional clinical training several times a year. This will ensure that when you purchase PIOON products, you will have more clinical solutions, processes and technical support, making your surgery smoother and more effective.

Warranty and After-sales

The expected service life of the product is no less than 5 years according to the medical device. After 5 years, our company will provide product testing. If all indicators meet the requirements, it can continue to be used. During the product life cycle, if it is not damaged by human factors, our company will provide free repair including freight, or arrange engineers to provide free on-site inspection services.

Registration and customs clearance

PIOON has a professional legal team that can help you register in your country. We sell products in more than 80 countries and regions around the world, so we are very familiar with the customs declarations of various countries and can help you avoid various problems when your products enter the country, and even the high risk of being detained or confiscated.

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PIOON Lipo наконечник Pro

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