How to Check if a Laser Device is FDA Approved & Safe

If you're deciding whether or not to go through with laser hair removal, you should do your homework to make sure that you are receiving safe treatment.  One part of this process is making sure that the equipment you will be using is approved by the FDA as being safe.

​Unfortunately, the FDA web site can be quite confusing and isn't really consumer friendly.  However in this guide, I'm going to show you (with an example) how you can do a lookup on the FDA database to do the necessary check ups before going ahead with treatment.

How does FDA Approval Work?

The FDA groups similar classes into a Classification Product Code.  So, for example, the classification code "GEX" contains all devices that are "Powered Laser Surgical Instruments".  

Here is how the GEX classification is listed on the FDA web site:-​

FDA classification GEX

As you can see, there is a clear description of the category and some information about the product code, radiation type, regulation number and applicable performance standards.

This particular product category is the one that home lasers fall into.  In order to be FDA approved, the manufacturers have to make sure that they can meet the necessary criteria to be added to this group.

The necessary criteria that needs to be met is defined in the Applicable Performance Standards section.  If you click on one of the two links, you'll be taken to a highly technical document of requirements that must be met.

FDA requirements doc 1

How to Look up a Particular Device

In most instances, you will need to do a look up on what's called the 510k database on the FDA web site.  

"A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR §807.92(a)(3)) that is not subject to premarket approval."

FDA Web Site​

This is a database of applications from manufacturers.  In pretty much all instances, a company will use a 510(k) form to apply for FDA approval.  The form allows the company to demonstrate that their product is "substantially equivalent" to existing products on the market and therefore doesn't need full premarket approval.

1. Visit the 510(k) Web Database Site

Click here to go to the 510(k) Premarket Notification site (link will open in a new window)

2. Enter Search Criteria

Once you visit the site, you'll be greeted with this:-

510k device lookup

In this example, let's search for the Tria 4X listing.

You have a number of options to search from, here are the most popular:-​

  • Device Name - "Tria" or "Tria Laser"
  • Applicant Name - "Tria Beauty"
  • 510k Number - "K090820"

Sometimes, if you're not specific enough, you'll have to search through a number of pages of records to find the right one.

3. Find the Correct Record and View Decision

tria_beauty_fda_lookup

In the example above, I search for "Tria Beauty" in the applicant name field.  Here I can see all the products that TRIA have had a 510(k) application for.

If you click on the product, you will see the full database record:​

Tria Lookup Decision

The important thing to note is the decision.  In this instance the decision is "Substantially equivalent" which means that the FDA has deemed the device substantially equivalent to existing devices on the market such that the device can get FDA approval without the full premarket approval.

If you lookup a product, and the decision is substantially equivalent, then you can consider the device safe.

"I Can't Find The Device"

If you're struggling to find the device, then you may wish to try some of these techniques in order to help.​

Search Google directly for the 510(k) Number

​Sometimes you can obtain the 510(k) number directly from Google by typing in a search phrase similar to this one that I used:-

tria 510k google search

In the results listings you'll often find a number of key documents that contain the 510(k) number that you can then use to query the 510(k) database.  For example, with the above search I managed to find a page with the following:-

Tria 510k research

I also managed to find this document:

Tria 510K Summary

Contact the CDRH-Division of Industry & Consumer Education

If you still can't find the device, then you can contact the Division of Industry and Consumer Education through one of the following means:-

Telephone

1-800-638-2041 or
301-796-7100

Fax

301-847-8149

Email

dice@fda.hhs.gov

What Does 510(k) FDA Approval Actually Mean?

This type of approval gives manufacturers general permission to market their devices, however it does not give them permission to advertise the lasers for hair removal or wrinkle treatment.

For these types of claims, and for claims such as "permanent hair reduction", a different type of FDA approval is needed.​

"Manufacturers should be aware that receiving an FDA clearance for general permission to market their devices does not permit them to advertise the lasers for either hair removal or wrinkle treatment, even though hair removal or wrinkle treatment may be a by-product of any cleared laser procedure"

FDA Web Site

Paul
 

I'm a computer science graduate, have a passion for self development and created this site as a side project due to the lack of complete, understandable, helpful and truthful information about hair removal available online. Over the next few years, I want to develop this site into being the place to visit for hair removal consumer information. Got any questions? Write to us below: