Dr Hansen,
I had thought about bring Zerona on and did not. As stated, Erchoina had this machine out for years with little following. What sold me against it is that the machine does not target an area, it causes overall loss. If the wavelength that they use does manipulate a fat cell, then why does it not act locally? why would increasing exposure to an area not increase efficiency in only that area? Santa Barbara Medical made a deal where they market the Zerona with a vitamin plan, Carnatine, Green Tea Extract, Niacin and Ginko. I asked the rep if she would leave the machine for a trial, she refused. I did a trial watching my diet and my office manager taking the vitamins (my own substitute) and doing light exercise. I indeed I did loose the inches that they claim but I did it without their machine. It probably would drive in customers though.
Dr. Pitera

Well, your skeptism made you the fool. ZERONA was just FDA cleared and proven to loose fat and inch loss. We have two ZERONA's at our location and love the results. As with anything - including lipo - you will have some that do not have much result. However, overall, everyone loves it. We are very happy to have given it a try and our clients are as well.

SSB,

If you have been in this market long enough, you will realize that the FDA approval means almost nothing other than the system is safe. I am still waiting for long term studies (anything longer than 2 weeks). If there is a study out there I would appreciate knowing how to get a copy. They refuse to publish any and that makes me question why. The above post from was from a year ago. The company has been telling me that they have long term studies they are working on for over 2 years. My assumption is that the long term studies are not showing efficacy otherwise they would have been published.

As you can see from Dr. Pitera's post the laser may have little benefit. That is why all the "practices" using Zerona put all of their patients on low cal diets with exercise and supplements. I wish that the Zerona was as beneficial as they claim as I would have 5 to 10 units working for me. If they are willing, I am willing to do a study of their system in a double blind placebo controlled study looking at patients with just the Zerona and a sham laser and then look at the Zerona with the diet and exercise changes against a sham laser with diet and exercise along with supplements. The only thing Zerona would need to do is to supply the Zerona and the "sham" laser. I will do the rest and will publish monthly reports on this site. I will also do a longer term study for a minimum of 6 months post treatment.

The company knows how to contact me.

HOT OFF THE PRESSES-- AND HARD TO BELIEVE--
FDA Grants Market Clearance for Erchonia’s Zerona Laser
Proven safe and effective for circumference reduction of the waist, hips and thighs

McKinney, TX August 30, 2010 – Erchonia Corporation, the world’s leading manufacturer in low-level laser technology, has been granted market clearance by the U.S. Food and Drug Administration for the non-invasive body contouring device, the Zerona. The Zerona is the first non-invasive aesthetic device to receive FDA market clearance in the U.S. for circumferential reduction of the waist, hips, and thighs.

The FDA granted market clearance following the completion of a placebo-controlled, randomized, double-blind, multi-site clinical investigation evaluating sixty-seven study participants. The results obtained from that study demonstrated an average inch loss reduction of 3.65 inches across patient’s waist, hips, and thighs in as little as two weeks. The clinical trial, absent of diet restrictions, exercise requirements, or any other adjunctive components properly illustrated the clinical utility of the Zerona and set the precedent on how aesthetic devices should be evaluated.

FDA clearance for body contouring is just the latest clearance in a long line for Erchonia’s low-level laser devices having already earned FDA market clearances for breast augmentation (2008), acne (2005), liposuction (2004), and chronic pain (2001).

The Zerona emits a low-level, or cold, output energy that generates no thermal effect on the body’s tissue eliminating any risk to the patient. Zerona has been clinically proven to target fat cells causing their immediate collapse thereby significantly reducing body volume. Through a natural process of fat removal, the laser-released fat is safely removed and broken down, providing patients with a truly non-invasive procedure without side effects or downtime.

“Zerona is scientifically-proven to be both safe and effective, and this most recent FDA clearance simply validates the research supporting this application,” says Charlie Shanks, vice president of Erchonia. “Zerona’s FDA clearance makes it even more unique in the marketplace and we are excited to continue the momentum with a new, integrated marketing campaign.”

Having no predicate devices to base FDA clearance on, the Zerona had to undergo a review process called de novo, which is completed by the FDA in an average of 750 days. Erchonia submitted clinical data in August 2008 and was granted approval for safety and effectiveness nearly two years later.

Here's the link to the actual FDA letter.
http://www.myzerona.com/files/uploads/1/file/K082609_Non-Invasive%20Zerona.pdf

If you read it carefully, you will see it is totally about the classification of the device, and whether it's category III or category II.

It does not state that the approval was based on the results of any particular scientific study.
It does not state that the Zerona is effective, or has clinical utility.

It just states that the Zerona is reasonably safe, and classifies the device on that basis.

All that other stuff is from Erchonia's press release, not the FDA.

"TF"-- It appears to me that the Erchonia/Zerona people submitted a PMA document and have actually carved out a new device niche in the "Therapeutic Devices" category for a "low level laser for aesthetic use". This looks similar to what the Endermologie people did about ten years ago in the "therapeutic massager" category adding the claim of "temporary reduction of cellulite".

Now it appears that any company that submits a premarket submission for a device with the same wavelength and energy settings can probably "ride Erchonia's coattails" and receive a 510(k) for the indication of "non-invasive dermatological aesthetic treatment for the reduction of the circumference of hips, waist and thighs...". Looks like another placebo device category has been opened up...

Exactly!

FDA approval of medical devices is not particularly helpful for consumers. It's not about efficacy, just categorization. For example, the Zeltiq cryolipolysis device just received 510(k) approval -- for "skin cooling", not "fat treatment". But that won't be how these machines are marketed to the general public....

TF,
Zeltiq just got its FDA approval for permanent fat reduction.

I just heard that...but can't find the FDA documentation to read the details for myself. Anybody have any 510(k) info on that?

Colleagues who jumped on the Zerona bandwagon are now leaving it idle due to poor results. LipoEx gets consistent results as does VelaShape. Zeltiq is a long treatment that only covers a small area and the results don't seem as good as with lipoEx according to spas that have both technologies. Exilis is a faster version of LipoEx and gets good results on par with LipoEx except doesn't treat visceral fat as well. Problem with using heat for visceral fat is that it is temporary unless the underlying endocrine problem is addressed concurrently. Velashape and LipoEx used together is one of the best noninvasive contouring treatments on the market but not many places have both. Zerona was presented at a liposuction symposium directly preceeding the American Academy of Cosmetic Surgery 25th anniversary meeting in January 2009. The speaker was very blunt with the inconsistencies of results and nothing that she said made me want to buy it. I was surprised to see so many pop up the following 2y but they were mostly by people who weren't at the meeting. They've done a great job marketing and making it affordable for medical spas to add to their armamentarium but that doesn't help your practice grow if your clients are not getting reasonable results.

Thanks beautydoc for your advice regarding the latest bandwagon of fat reduction equipment. I am a velashape owner and am thinking about buying a zerona, zeltiq, or the LipoEx for my practice. Can you share your experience on the LipoEX RF procedure? IS it painful? Result consistent for each case?

LipoEx feels like a hot stone massage and is not painful but very relaxing. Our results have been very consistent in clients who exercise, stay hydrated and make changes in their diet but not good at all in clients who are sedentary and make no dietary changes. Best results have been in people who are on a more rigorous diet and exercise plan as it seems to escalate fat loss more synergistically than expected. I'd look into Exilis too, it's the same technology as LipoEx, less expensive and the treatment time is 4-5 minutes per small area, so an abdomen would take about 10 mintues, abdomen and flanks 20 minutes compared to lipoEx at about an hour to hour and a half. The only downside of Exilis is that it only penetrates 4cm compared to 7cm for lipoEx so no effect on visceral fat. I don't think it is the best way to reduce visceral fat. Losing weight overall, increasing growth hormone, low GI diet and this great natural product called ProArgi9 Plus have helped me reduce my own visceral fat (which was normal to start anyways) but more importantly, has reduced the visceral fat and blood pressure of many clients. I have several who were on 2-3 antihypertensives that are no longer needing them and it's an easy sell in my office.

Most of our customers testimonials are rather positive regarding zerona, thought the absence of long term studies is an issue for sure! I guess it will take much time before we can make a safe, final conclusion!