Get the free Electro-Light Therapy 510(k) - accessdata fda

This document is a premarket notification summarizing the Electro-Light Therapy device, including its intended use for providing topical heating and temporary relief of muscle and joint aches, among

How to fill out electro-light formrapy 510k

How to fill out Electro-Light Therapy 510(k)

1. Gather necessary documents including product specifications and labeling.
2. Prepare a comprehensive description of the Electro-Light Therapy device.
3. Conduct and document any required safety and efficacy testing.
4. Compile clinical data and any literature relevant to the device's use.
5. Fill out the 510(k) form, ensuring all sections are completed accurately.
6. Submit the completed 510(k) application to the FDA.
7. Respond promptly to any feedback or requests for additional information from the FDA.

Who needs Electro-Light Therapy 510(k)?

1. Manufacturers of Electro-Light Therapy devices.
2. Companies seeking to market Electro-Light Therapy devices in the U.S.
3. Healthcare providers who want to understand the regulatory status of the devices they use.

People Also Ask about

What is the 501k process?

The 510(k) regulatory pathway is a submission process that medical device manufacturers use to get clearance from the FDA to market an eligible product in the U.S. Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA, which includes information about the device's intended

What is the rejection rate for 510k?

The FDA 510(k) Program is occasionally referred to as premarket notification. It allows a new medical device to gain FDA approval by establishing a set of similarities to a current medical device that is already on the market.

How long does 501k approval take?

The Electro-Light is an infrared therapy device that can be used in conjunction with a separate muscle stimulation machine. The Electro-Light uses a patented transparent electrode called the Dual-Sided Electrode™.

What does 510 K clearance mean?

Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Applicants with outstanding review issues will be notified within 100 days.

How long does FDA 510 K approval take?

The FDA 510(k) submission process is a critical gateway for medical device manufacturers seeking approval for their products in the United States. However, a concerning trend has emerged – a staggering 25% of these submissions are facing rejection due to lack of completeness.

For pdfFiller’s FAQs

What is Electro-Light Therapy 510(k)?

Electro-Light Therapy 510(k) is a premarket submission made to the FDA for devices intended to use electrical energy in therapeutic applications, demonstrating that the device is safe and effective for its intended use.

Who is required to file Electro-Light Therapy 510(k)?

Manufacturers of medical devices that utilize electro-light therapy and wish to market their products in the United States are required to file a 510(k) submission with the FDA.

How to fill out Electro-Light Therapy 510(k)?

To fill out the Electro-Light Therapy 510(k), manufacturers must complete the FDA's 510(k) submission form, provide required documentation, include device descriptions, labeling information, and any relevant clinical data demonstrating safety and effectiveness.

What is the purpose of Electro-Light Therapy 510(k)?

The purpose of the Electro-Light Therapy 510(k) is to provide evidence to the FDA that a new electro-light therapy device is safe and effective, facilitating its market entry in compliance with regulatory standards.

What information must be reported on Electro-Light Therapy 510(k)?

The information required includes the device's name and description, intended use, manufacturing information, labeling details, performance data, substantial equivalence to a predicate device, and any safety or effectiveness data supporting the device's claims.