Monday, July 26, 2010

The Laser

Not long ago I mentioned the laser when I was discussing another topic and said that I would get back to that. I wanted to learn about and explain the FDA approved uses of the laser in regards to medical procedures. I am torn now about writing this post even though I spent an hour or more searching for the answers, because my intent is to enlighten the reader not confuse them more!

The laser, which is used in surgery, hair removal and even physical therapy, is a device that emits a very intense light, a single wave length, with non ionizing radiation. We don't generally think of this radiation as harmful or cancer causing. It could however, cause skin reddening and in the case of surgery, side effects are possible. The light is so intense that it can "burn" away tissue, hair, wrinkles even. In the case of wrinkles, the laser is essentially removing skin and is abrasive. The laser is used to remove tattoos as well. IN fact, I have had that done myself.

What I understand, and I could be mistaken, is that the device itself is approved by the FDA per manufacturer. The manufacturer has to abide by certain safety standards, including monitoring the radiation emissions. Each company has to label their devices specifically, and report any adverse events to the FDA. If a manufacturer wants to market the device, it has to submit an application and data to show that the device does what it says and does so without serious adverse consequences. This is the same criteria put on medication applications.

My quest was to find the FDA approved uses for the laser itself, but it seems that there isn't a clear list. It is not as simple as say, looking up Wellbutrin and seeing that it is indicated for depression. It is true that once the device or medicine is approved clinicians can use it as they see fit. I wanted to see what they could advertise for- which I still do not understand. One source of information on the FDA website implied that with safety approval (and not clinical study) a company could market but not advertise. These leads me to believe that the two words are not interchangeable in the medical world. Instead, market just appears to mean sell.

With regard to hair, I did learn that the laser can only be advertised as a means to reduce hair not to remove it! With regard to wrinkles, some laser devices are treatment "approved" while others are not. The consumer can look up the particular device to see what the FDA did give the ok on. Consumers are also encouraged to talk to the clinician and ask to see the labeling for that particular device.

I feel that is it safe to say that the laser, but not ANY (they have separate approvals) laser, is thought to be effective in these areas: surgery, eye surgery, hair reduction, wrinkle treatment, dental care, and maybe even pain reduction. Please read more here.

I DID finally email the FDA to see if I could get a list of approved laser uses - re promotable uses. Will let you know if I get a response.

Not just anyone can use a laser. There are also certifications and licensing issues for the practitioner. I can say and WILL say, the FDA did not at any time note the laser as an effective method for quitting smoking.

No comments: