Laser Hair Clinic Mississauga: Checking if a Laser Device is approved by the FDA
10/10/2018 10:17
When you are trying to decide whether or not to go ahead with laser hair removal, there are a couple of things to consider. For starters, what were the results of the patch test? Secondly, is the laser hair clinic Mississauga using devices that have been approved by the FDA? The idea is to make sure that the procedure is safe for you. Unfortunately, the FDA site can be a bit difficult to navigate. If you want to check whether a device is listed, here is everything you need to know:
How FDA approval works
The FDA has similar devices in the same product code. For example, the classification code GEX might have all the devices that are powered and surgical. On the website, each category is described in details with information such as regulation number, radiation type, and the performance standards. Normally, manufacturers must meet certain criteria to be added to the groups and this criterion is found under the performance standards part.
Looking up a specific device
A lot of times, you might need to look at the 510K database. This database is a submission made by manufacturers before they present their products to the market. They are then tested for effectiveness and safety. However, there is another category for devices that have been approved without pre-market testing. Note that when entering the search number, you have to be specific so that you do not spend a lot of time scrolling through data.
Finding the proper record and viewing the decision
After you enter a product, you might find a list of devices used in every laser hair clinic Mississauga. Be sure to find the exact one they are using. More importantly, note what decision the FDA came to. If a device has been deemed substantially equivalent, for example, it means that it is like other devices in the market. If you are unable to find a device you can consider searching it directly on Google or contacting the division of industry and customer education.
Every reliable laser hair clinic Mississauga will seek to use lasers that are FDA approved. In general, this means that the manufacturer had to get permission to advertise their lasers for the job. Be sure that the device falls under the category of what it promises to deliver.
When you are trying to decide whether or not to go ahead with laser hair removal, there are a couple of things to consider. For starters, what were the results of the patch test? Secondly, is the laser hair clinic Mississauga using devices that have been approved by the FDA? The idea is to make sure that the procedure is safe for you. Unfortunately, the FDA site can be a bit difficult to navigate. If you want to check whether a device is listed, here is everything you need to know:
How FDA approval works
The FDA has similar devices in the same product code. For example, the classification code GEX might have all the devices that are powered and surgical. On the website, each category is described in details with information such as regulation number, radiation type, and the performance standards. Normally, manufacturers must meet certain criteria to be added to the groups and this criterion is found under the performance standards part.
Looking up a specific device
A lot of times, you might need to look at the 510K database. This database is a submission made by manufacturers before they present their products to the market. They are then tested for effectiveness and safety. However, there is another category for devices that have been approved without pre-market testing. Note that when entering the search number, you have to be specific so that you do not spend a lot of time scrolling through data.
Finding the proper record and viewing the decision
After you enter a product, you might find a list of devices used in every laser hair clinic Mississauga. Be sure to find the exact one they are using. More importantly, note what decision the FDA came to. If a device has been deemed substantially equivalent, for example, it means that it is like other devices in the market. If you are unable to find a device you can consider searching it directly on Google or contacting the division of industry and customer education.
Every reliable laser hair clinic Mississauga will seek to use lasers that are FDA approved. In general, this means that the manufacturer had to get permission to advertise their lasers for the job. Be sure that the device falls under the category of what it promises to deliver.