Lasers: What Does FDA-Approval Mean?

First let us inform you that almost every laser manufacturing company and every laser practitioner that uses the device will tell you that it is...

If you’ve been doing any laser research recently, then you’ve probably come across the term “FDA-approved”. We hear this phrase over and over in our industry as it is meant to give credibility to the latest and greatest cosmetic laser technology. But, what does the term really mean? How does it impact your decision to have a certain treatment or procedure? Or should it?

First let us inform you that almost every laser manufacturing company and every laser practitioner that uses the device will tell you that it is “FDA-approved”. This tells you that the device has met certain requirements of the FDA—the United States Food and Drug Administration. It does not tell you, however, how effective the device is at treating a particular condition.

What are the requirements of the FDA for approval? They can vary, but for the most part, for a laser, the manufacturer must submit an application to the FDA stating that they intend to market the device to treat a certain condition. They also must submit one or more clinical trials done where the laser proves safe and effective in treating the skin condition indicated in the study. Only after these requirements have been met will the FDA approve a device.

So, what’s the issue? Well, the FDA-approval process has a couple inherently large flaws. First, the physicians who perform the clinical trials for the devices are generally compensated to do so by the device’s manufacturing company. They often get to use the device for free, and as a result, they are naturally biased to demonstrate positive results. This problem isn’t just in the medical device industry…it happens in all areas of medicine. Anything that needs approval by the FDA, including medications and vaccines.

The second problem is that approval is more reliant upon device safety than treatment efficacy. Take this example: if a clinical trial for a laser demonstrates that only one out of 10 people treated with it showed improvement and none of the 10 had any side effect or harm from the device, then that may still pass FDA standards. This means that the manufacturer could advertise the device as being “effective” for the condition, even though the rates of success in the clinical trials were very low. Unfortunately for consumers, the FDA looks more closely at safety than it does at efficacy.

This brings us to our final point: FDA-approved is a misnomer. The FDA simply grants “clearance” to a device. Clearance to the manufacturer to market it and sell it for use on the public. The FDA doesn’t even recognize the term “FDA-approved” because it implies that it approves of the use of a device for a particular condition. Nothing could be further from the truth. Instead of advocating for the use of the device for a condition, the FDA simply allows it to be used. Advocating and allowing are two very different things, and patients need to understand the difference when considering a treatment with an “FDA-approved” device.

No matter the semantics, the term “FDA-approved” is widely used and accepted by most laser practitioners and patients. It is important, though, to understand what that term really means. It is more of an indication of the safety of a device rather than its efficacy.

This is where consumer research and education become so important. You simply can’t rely on advertising to tell you if something works or not. You need to ask questions, be informed and learn all you can about your condition and the device that you are considering for treatment.


View All Blogs

Contact us for a FREE Consultation
BOOK A CONSULTATION
  • 5 star ratingLori was so knowledgeable and accommodating! She suggested a non surgical brow lift and it did wonders to help my... Read More

    Cristen F. Avatar
    Cristen F.
    8/26/2021

    5 star ratingThank you to all the Celibre Medical staff for always making me feel welcomed. I've been coming to this facility... Read More

    Darius T. Avatar
    Darius T.
    8/24/2021

    5 star ratingI was pleased about my first visitation. Kevin, the director was very professional, he explained and answered all my concerns,... Read More

    Yuka M. Avatar
    Yuka M.
    8/11/2021
  • 5 star ratingI have been going to Lori at Celibre for years. I consider her an artist in her approach to... Read More

    Debbie S. Avatar
    Debbie S.
    7/30/2021

    5 star ratingFor as long as I can remember my Dad has been the sunshine of my life. There was... Read More

    Jen O. Avatar
    Jen O.
    4/07/2021

    5 star ratingCustomer service- clarifying conversations- the desired results! These are some of the proficiencies you'll encounter with these skilled professionals. They... Read More

    Laila R. Avatar
    Laila R.
    4/04/2021
  • 5 star ratingLori is absolutely remarkable. She works miracles on my look. When I leave I look 10 yrs younger and it's... Read More

    roxanne w. Avatar
    roxanne w.
    4/02/2021

    5 star ratingI've been going to Celibre and getting treatments from Lori for over 10 years now. I've had dysport, fillers, and... Read More

    Lucy L. Avatar
    Lucy L.
    3/30/2021

    5 star ratingI just recently had the profractional laser done at Celibre in December. It has literally shaved 10 years off... Read More

    Dannie A. Avatar
    Dannie A.
    2/25/2021
  • 5 star ratingI highly recommend Lori for any skin concerns or treatments that Celibre offers! She took the time to listen to... Read More

    R V. Avatar
    R V.
    2/07/2021

    5 star ratingI normally do not write reviews but I have to say that Celibre is the best. The office staff... Read More

    Debbie S. Avatar
    Debbie S.
    12/31/2020

    5 star ratingI am so impressed with the service and quality from Celibre. I drive an hour for injections from Lori Haney.... Read More

    Robyn W. Avatar
    Robyn W.
    12/10/2020
  • 5 star ratingThe staff here are very welcoming and informative! I'm the type to ask to ask questions on anything new I... Read More

    Angilina M. Avatar
    Angilina M.
    10/09/2020

    5 star ratingThank you Celibre for making me feels so much better! Lori is a miracle worker! Fine lines so improved... Read More

    roxanne w. Avatar
    roxanne w.
    10/01/2020

    5 star ratingAlthough I'm new fairly new to Celibre, I've been very pleased with the service so far. Honesty is very important... Read More

    Anna C. Avatar
    Anna C.
    9/24/2020
  • 5 star ratingI loooove how the Celibre's staff is so knowledgeable in facial construction, symmetry & features and don't focus just on... Read More

    LadyLoops L. Avatar
    LadyLoops L.
    8/20/2020

    5 star ratingBeen here several times for laser tattoo removal with Kevin. Face tattoos are painful to remove. Kevin's communication with you... Read More

    Timothy J. Avatar
    Timothy J.
    7/25/2020

    4 star ratingCalled for a consultation and spoke with Kevin I told him I was interested in my smile lines so he... Read More

    Sheena S. Avatar
    Sheena S.
    7/06/2020
  • 5 star ratingI cannot say enough great things about this place. The front desk staff are super personable, nice and welcoming. Kevin... Read More

    Amber W. Avatar
    Amber W.
    6/16/2020

    5 star ratingI was referred to Celibre by a friend and was not disappointed. The office is clean, open and had great... Read More

    Lauren C. Avatar
    Lauren C.
    6/02/2020

    5 star ratingAwesome Staff and love the laser hair removable service... best thing I've done so far!!!

    Jackie A. Avatar
    Jackie A.
    2/27/2020
  • 5 star ratingOmg !!! What to say... I have a birthmark on my face and tried my whole life to get rid... Read More

    Coco C. Avatar
    Coco C.
    1/22/2020

    Went in to have some small skin tags removed as well as have some botox injected into my forehead...I didn't... Read More

    Jake Haney Avatar
    Jake Haney
    7/11/2019

    5 star ratingWhat an amazing experience!!! Not only did I love my results (which can we be honest, that's why we are... Read More

    Faith P. Avatar
    Faith P.
    7/11/2019
  • 5 star ratingVery professional and patient! They will educate you, and answer all of your questions.

    Wendy R. Avatar
    Wendy R.
    7/02/2019

    5 star ratingI had gone to Celibre 10 years ago and had a great experience- so I decided to go back and... Read More

    Andrea O. Avatar
    Andrea O.
    5/19/2019

    5 star ratingI had gone to Celibre 10 years ago and had a great experience- so I decided to go back and... Read More

    Andrea O. Avatar
    Andrea O.
    5/18/2019
  • 5 star ratingVery clean, kind friendly staff, provided me with a lot of preliminary information. I had a lot of questions and... Read More

    Sarah D. Avatar
    Sarah D.
    5/15/2019

    5 star ratingLori is an angel from heaven. I mean it!!

    I am a first time injector and was relatively nervous about...
    Read More

    Erin M. Avatar
    Erin M.
    5/05/2019

    5 star ratingLori is an angel from heaven. I mean it!!

    I am a first time injector and was relatively nervous about...
    Read More

    Erin M. Avatar
    Erin M.
    5/03/2019
  • 4 star ratingI had a great experience here. The staff is very friendly and welcoming. Nurse Kevin used Restylane to fill under... Read More

    Tiffany C. Avatar
    Tiffany C.
    4/03/2019

    5 star ratingStars to the moon for this wonderful place. Talk about an educated and highly skilled staff. I was beyond satisfied... Read More

    Nikki N. Avatar
    Nikki N.
    3/26/2019

    5 star ratingI love this place and the people that work here. Lori is the BEST! She takes the time to explain... Read More

    Rilee S. Avatar
    Rilee S.
    12/18/2018
  • 5 star ratingI called to ask for information. Very pleasant experience, not put in hold, very helpful and not pushy about making... Read More

    Esther L. Avatar
    Esther L.
    6/24/2018

    5 star ratingThe wait is finally over! I've been searching for a great place to help me take care of my skin... Read More

    Colleen B. Avatar
    Colleen B.
    4/04/2018

    5 star ratingGreat service and results. Lori was great at getting the look I wanted.

    Anita K. Avatar
    Anita K.
    11/28/2017
  • 5 star ratingI am blown away. The Office is lovely, the receptionist super nice, even the owners is hot, but really it's... Read More

    Meredith J. Avatar
    Meredith J.
    9/28/2017

    5 star ratingI had an amazing experience there. After going back and forth with one of the owners, Kevin, to make... Read More

    Sandra C. Avatar
    Sandra C.
    9/18/2017

    5 star ratingI highly recommend Celibre as a great place for laser treatments. Office is peaceful, front desk Associate friendly and waiting... Read More

    Téa M. Avatar
    Téa M.
    8/02/2017
  • 5 star ratingThis place is great. The staff is very friendly. Nurses are kind and personable. They meet great... Read More

    Jonathan Z. Avatar
    Jonathan Z.
    5/12/2017

    4 star ratingI didn't even know this place existed, only came in to accompany my mom for her visit. They offer free... Read More

    JeL C. Avatar
    JeL C.
    4/25/2017

    5 star ratingHave seen Lori twice for laser treatments on face. Everyone is very friendly and Lori is not only professional,... Read More

    Sofia Y. Avatar
    Sofia Y.
    4/03/2017
  • 5 star ratingI had a laser treatment on January 2017 with Lori Haney. After a month I came back to see Lori... Read More

    Rowena P. Avatar
    Rowena P.
    3/22/2017

    First of all, Lori Haney, the RN, is the kindest and most genuinely concerned medical professional I've ever had the... Read More

    Fatima Safi Avatar
    Fatima Safi
    10/24/2016

    5 star ratingI found celibre here on yelp, i was looking for a dermatologist and i went with the one with the... Read More

    Ana M. Avatar
    Ana M.
    6/20/2016