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510 (K)SUMMARY3K123542IAY12I. General InformationSubmitter:Theron Medical Laser Systems. Inc.
3130 Coronado Drive
Santa Clara, *CA 95054. Contact Person:Pamela M. Beckman
Regulatory Consultant
T 925
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How to fill out 510 k summary
How to fill out 510 k summary
01
Gather all necessary information and documentation for the device being submitted.
02
Create a concise summary of the device, including its intended use, main features, and performance characteristics.
03
Provide a comparison to a predicate device, if applicable.
04
Include any relevant testing data and results.
05
Make sure to follow the specific formatting and content requirements outlined in the FDA guidance document for 510(k) submissions.
Who needs 510 k summary?
01
Medical device manufacturers who are seeking FDA clearance to market a new device in the United States.
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What is 510 k summary?
510(k) summary is a document submitted to the FDA to demonstrate that a medical device is substantially equivalent to a predicate device.
Who is required to file 510 k summary?
Manufacturers of medical devices seeking FDA approval.
How to fill out 510 k summary?
You need to provide detailed information about the device, comparison to predicate devices, and evidence of safety and efficacy.
What is the purpose of 510 k summary?
The purpose is to demonstrate the safety and effectiveness of a medical device and obtain FDA approval for market distribution.
What information must be reported on 510 k summary?
Information about the device, its intended use, technological characteristics, comparison to predicate devices, and evidence of safety and efficacy.
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