Get the free LiteCure Therapy System 510k summary K103511 - Chirobase

Page IOF 3 510(k) SUMMARY JAN 2 52DB Applicant Sinecure, LLC 250 Corporate Blvd., Suite B Newark, Delaware 19702 Tel: 3027090408 Fax: 3027090409 Date November 11, 2010, Correspondent Device Name Classification

How to fill out litecure formrapy system 510k

How to fill out LiteCure Formrapy System 510k?

1. Start by gathering all the necessary information and documents required for filling out the LiteCure Formrapy System 510k. This may include the device description, intended use, indications for use, and any supporting data or clinical studies.
2. Begin the form by providing the basic details of the device, such as the brand name, model number, and any other identifying information. Be sure to include accurate and up-to-date contact information for the manufacturer or submitter.
3. Clearly state the intended use of the LiteCure Formrapy System 510k. This should describe the specific medical condition or procedure that the device is intended to diagnose, treat, or assist with. Use clear and concise language to accurately convey the purpose of the device.
4. Include a thorough description of the device, highlighting its key features, design, and functionality. It's important to provide enough information to give a clear understanding of how the device works and what sets it apart from similar products on the market.
5. When filling out the LiteCure Formrapy System 510k, it is crucial to adequately address any potential risks or hazards associated with the device. This includes outlining any potential adverse events, precautions, or contraindications that users should be aware of. Be sure to reference any relevant studies or literature that support the safety and effectiveness of the device.
6. Attach any necessary supporting documentation, such as clinical study reports, laboratory test results, or data from preclinical testing. This will help provide a comprehensive overview of the device's performance and safety.
7. Proofread the completed LiteCure Formrapy System 510k thoroughly to ensure all information is accurate and complete. Double-check that all sections have been filled out accurately and that all necessary attachments have been included.

Who needs LiteCure Formrapy System 510k?

1. Medical professionals and healthcare facilities in need of an advanced therapeutic system for treating various medical conditions may require the LiteCure Formrapy System 510k. This can include hospitals, clinics, physical therapy centers, and rehabilitation facilities.
2. Patients suffering from acute or chronic pain, musculoskeletal conditions, or soft tissue injuries can benefit from the LiteCure Formrapy System 510k. This device offers advanced laser therapy that may provide non-invasive, drug-free pain relief and promote tissue healing.
3. Researchers or individuals involved in clinical studies, medical device evaluations, or scientific investigations may need access to the LiteCure Formrapy System 510k. It can be utilized to explore the device's effectiveness, safety, and potential applications in the field of healthcare.

In summary, the LiteCure Formrapy System 510k should be filled out accurately and thoroughly, providing all necessary information about the device's features, intended use, and potential risks. Medical professionals, patients, and researchers are among those who may require the LiteCure Formrapy System 510k for its advanced therapeutic capabilities.

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What is litecure formrapy system 510k?

The LiteCure FormaRay System 510k is a premarket submission made to the FDA to demonstrate that the device is safe and effective.

Who is required to file litecure formrapy system 510k?

Manufacturers of medical devices are required to file the LiteCure FormaRay System 510k with the FDA.

How to fill out litecure formrapy system 510k?

The LiteCure FormaRay System 510k must be filled out according to the FDA's guidelines and regulations for premarket submissions.

What is the purpose of litecure formrapy system 510k?

The purpose of the LiteCure FormaRay System 510k is to demonstrate that the device is substantially equivalent to a legally marketed device.

What information must be reported on litecure formrapy system 510k?

The LiteCure FormaRay System 510k must include information on the device's technical specifications, intended use, and scientific data to support its safety and effectiveness.