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This document summarizes the safety and effectiveness of the stLase dental laser device, detailing its intended use, predicate device comparison, and technical specifications required for FDA approval.

How to fill out 510k summary of safety

How to fill out 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

1. Determine if your device requires a 510(k) submission.
2. Gather all relevant device information including intended use and technological characteristics.
3. Fill out the 510(k) form with your device's specific details and include a summary of safety and effectiveness data.
4. Provide comparison to predicate devices in your summary, highlighting similarities and differences.
5. Summarize any testing or clinical data that supports your claims.
6. Ensure all references and citations are properly included.
7. Review and revise your summary for clarity and completeness before submission.

Who needs 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS?

1. Manufacturers of medical devices that are not exempt from 510(k) requirements.
2. Companies introducing new devices that are substantially equivalent to existing devices.
3. Entities looking to market a device intended for human use in the USA.

People Also Ask about

What are class 1, class 2, and class 3 devices?

Class I (low to moderate risk): general controls. Class II (moderate to high risk): general controls and Special Controls. Class III (high risk): general controls and Premarket Approval (PMA)

How long does 501k approval take?

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.

What is the difference between FDA 510k and CE?

CE marking means Conformité Européenne or European conformity in French. And as the name suggests, it proves product compliance with European requirements that ensure specific safety, health, and environmental protection standards. A 510(k) is a premarket submission made to the FDA.

How long will it take my 510 K to be cleared by the US FDA?

Once the FDA have received your submission, the FDA will officially start the clock on your decision timeline. At the time of writing the FDA states that a traditional 510(k) decision should be provided within 90 days.

What is the 501k process?

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.

What is the difference between 510k de novo and PMA?

PMA submissions are intended for high-risk devices, whereas De Novo and 510(k) are suitable for lower-risk devices with suitable predicates. Choosing the right submission pathway depends on various factors, including your device's risk level, the availability of predicates, and the resources you have available.

What are the different types of 510k?

Types of 510(k)s. If your medical device is eligible under premarket notification criteria, there are three types of 510(k)s: Traditional, Abbreviated, and Special. The FDA offers separate checklists for the Traditional, Abbreviated, and Special 510(k)s in its Refuse to Accept Policy for 510(k)s guidance document.

What are the three types of 510k?

Types of 510(k)s. If your medical device is eligible under premarket notification criteria, there are three types of 510(k)s: Traditional, Abbreviated, and Special. The FDA offers separate checklists for the Traditional, Abbreviated, and Special 510(k)s in its Refuse to Accept Policy for 510(k)s guidance document.

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What is 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS?

The 510(k) Summary of Safety and Effectiveness is a document submitted to the FDA by manufacturers of medical devices to demonstrate that their device is safe and effective, and substantially equivalent to a legally marketed device.

Who is required to file 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS?

Manufacturers of medical devices that are seeking FDA clearance to market their device need to file a 510(k) Summary of Safety and Effectiveness if their device is not exempt and is intended for human use.

How to fill out 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS?

To fill out a 510(k) Summary of Safety and Effectiveness, manufacturers should follow the FDA's guidelines, provide relevant information about the device, including its purpose, indications for use, safety and effectiveness data, and a comparison to predicate devices. Specific forms and templates from the FDA website can aid in the process.

What is the purpose of 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS?

The purpose of the 510(k) Summary of Safety and Effectiveness is to inform the FDA about the device's safety and effectiveness, and to provide assurance that it is substantially equivalent to existing devices that are already legally marketed.

What information must be reported on 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS?

The information that must be reported includes device descriptions, intended use, technological characteristics, clinical data, labeling information, and any testing that supports the device's safety and effectiveness.