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Erchonia XLR8 Laser Granted FDA Clearance for Pain Treatment

Erchonia XLR8 Laser Granted FDA Clearance for Pain Treatment

McKinney, TX – October 21, 2013 – Erchonia, the global leader in low level laser healthcare applications, today announces the company has received 510 (k) clearance from the U.S. Food and Drug Administration (FDA) to market its new XLR8 Laser for pain treatment.
Depending on the settings selected, the Erchonia XLR8 laser can provide temporary relief of chronic neck and shoulder pain; reduce pain after liposuction of the thighs, hips and stomach; or reduce post-surgery pain after breast augmentation.
The Erchonia XLR8 laser is a handheld device that uses low level laser technology to speed the recovery process following liposuction and breast augmentation by encouraging cell regeneration. The XLR8 laser is a noninvasive, safe way to manage pain—without negative side effects.
Steven Shanks, president of Erchonia comments, “The Erchonia XLR8 laser combines three FDA 510(k) market clearances into one device. With user-definable channels, an easy-to-use interface, and preset protocols, cold laser technology is now more flexible than ever before.”
For more information on the Erchonia XLR8 laser, please visit www.erchonia.com.

About Erchonia

Erchonia is the global leader in low level laser healthcare applications. Over the last 15 years, Erchonia has been conducting research and development with the world’s leading physicians to advance the science of low level lasers. Prior to market introduction, all Erchonia lasers are proven safe and effective through independent clinical trials. Currently thousands of Erchonia’s lasers are used daily to reduce body fat, eliminate pain, and treat acne. For additional information, visit www.erchonia.com.

Harvard Scientists Commend Erchonia for Excellence in Clinical Research for the Zerona Laser

Tuesday, August 6th 2013
In the latest volume of the medical journal, Lasers in Surgery and Medicine, three Harvard scientists concluded that Erchonia’s research for its Zerona low-level laser device has, “set the precedent on how aesthetic devices should be evaluated.”
McKinney, TX (PRWEB) August 06, 2013
In the latest volume of the medical journal, Lasers in Surgery and Medicine, three Harvard scientists reviewed the merits of laser therapy for body contouring and concluded that Erchonia’s research for its Zerona low-level laser device has, “set the precedent on how aesthetic devices should be evaluated.” One of the article’s authors, Michael Hamblin, PhD., is recognized as the world’s leading expert in low level laser therapy, making the praise all the more significant.
Zerona was the first noninvasive aesthetic device to receive FDA market clearance in the U.S. for circumferential reduction of the waist, hips and thighs. Erchonia tested the Zerona laser using a placebo-controlled, randomized, double blind, multisite clinical investigation evaluating 67 study participants. The patients treated with the Zerona laser experienced an average reduction of 3.51 inches across the waist, hips and thighs in just two weeks.
The article praised Erchonia’s clinical approach for Zerona, noting, “The clinical trial absence 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.”
Steven Shanks, president of Erchonia comments, “Having an expert such as Dr. Hamblin recognize the quality of our research and the clinical utility of Erchonia’s Zerona laser is truly an honor. For a small medical device manufacturer like Erchonia, quality clinical research is pivotal for our overall success. Erchonia’s research stands out in aesthetic medicine because more and more devices, such as Erchonia’s competitors, such as fat-freezing devices, are tested in non-randomized, non-controlled clinical trials.”
This is not the first time an independent review recognized the clinical utility of Zerona. An article published in Clinics in Plastic Surgery in 2011 stated, “Zerona is in a unique and beneficial category as it exemplifies a truly non-invasive approach, inducing slimming without cell death or upregulation of inflammation.”
For more information, please visit https://www.erchonia.com or http://www.myzerona.com.
About Erchonia
Erchonia is the global leader in low level laser healthcare applications. Over the last 15 years, Erchonia has been conducting research and development with the world’s leading physicians to advance the science of low level lasers. Prior to market introduction, all Erchonia lasers are proven safe and effective through independent clinical trials. Currently thousands of Erchonia’s lasers are used daily to reduce body fat, eliminate pain, and treat acne. For additional information, visithttps://www.erchonia.com. 

New Clinical Trial Proves Erchonia’s Verjú Laser System Safely and Effectively Improves the Appearance of Cellulite

Contact: Katie Cycan
Crier Communications
310-274-1072 x 207
New Clinical Trial Proves Erchonia’s Verjú Laser System Safely and Effectively Improves the Appearance of Cellulite
McKinney, TX – June 24, 2013 – Erchonia today announces its new Verjú low level laser system has been proven to safely and effectively treat cellulite in a double blind, randomized, multi-site and placebo-controlled clinical trial. In just two weeks with six treatments of Erchonia’s Verjú laser system, patients experienced a significant improvement in the appearance of cellulite in their thighs, buttocks and lower abdomen when compared with those treated with the placebo laser.
In the clinical trial, not only did the Verjú laser system improve the appearance of cellulite, but pre and post measurements showed it also significantly reduced the circumference of the waist, hips and thighs.
Dr. Robert Jackson, MD, who served as the lead investigator for the study, comments, “In contrast to other technologies, Verjú is non-invasive, safe and effective as a standalone procedure for significantly improving the appearance of cellulite after only two weeks.”
Charlie Shanks, vice president of Erchonia, adds, “Cellulite is present in 90 percent of post-adolescent women. Until now there has not been a proven non-invasive procedure to help with the appearance of cellulite. With this clinical trial, Erchonia’s Verjú laser system is now proven option to help with the appearance of those pesky dimples.”
Erchonia’s Verjú laser system is made up of five low level laser beams that sweep the area of concern for a total treatment period of 30 minutes. Without incisions, pain or even heat, the low level laser emulsifies adipose tissue beneath the skin to reduce the appearance of cellulite. Patients can continue their daily routines immediately following treatment, and there is no downtime or pain whatsoever.
Erchonia has been studying the effects of low level laser therapy on fat cells for over a decade. Erchonia’s Zerona laser iscleared by the FDA for the circumference reduction of the arms and the waist, hips and thighs. Other Erchonia lasers are FDA cleared for liposuction and breast augmentation assistance and the reduction of associated pain; for chronic neck and shoulder pain treatment; and for the treatment of acne.
For more information, please visit www.erchonia.com.
 
About Erchonia

Erchonia is the global leader in low level laser healthcare applications. Over the last 15 years Erchonia has been conducting research and development with the world’s leading physicians to advance the science of low level lasers. Prior to market introduction, all Erchonia lasers are proven safe and effective through independent clinical trials. Currently thousands of Erchonia’s lasers are used daily to reduce body fat, eliminate pain, and treat acne. For additional information, visitwww.erchonia.com

Erchonia Wins Philanthropy Award from Parker Seminars

Erchonia Wins Philanthropy Award from Parker Seminars

Erchonia, the global leader in low level laser healthcare applications, announces it has recently won Parker Seminars’ Philanthropy Award.
Parker Seminars, the largest chiropractic seminar organization in the world, awarded Erchonia along with other leaders in the chiropractic profession during its 2012 Parker Seminars event in Las Vegas from January 19 to January 21, 2012. Erchonia was chosen for the Philanthropy Award because of its generosity with services, time, and funds to support the chiropractic profession.
“We were honored to receive the Philanthropy Award, especially at such a prestigious event in the industry,” says Charlie Shanks, CCO of Erchonia Corp. “Receiving recognition for the work we do for the profession was the perfect way to start 2012. We couldn’t be happier to lend our support.”
Since its inception over 15 years ago, Erchonia has been a supporter of chiropractic studies and efforts and was recently instrumental in creating the first laser healthcare center in the country at Parker University in Dallas, Texas. The state-of-the-art facility offers the latest Erchonia technology along with a clinical setting for chiropractic interns to treat patients under the direction of qualified clinicians.
For more information, please visit www.erchonia.com.
About Erchonia
Erchonia is the global leader in low level laser healthcare applications. Over the last 15 years Erchonia has been conducting research and development with the world’s leading physicians to advance the science of low level lasers. Prior to market introduction, all Erchonia lasers are proven safe and effective through independent clinical trials. Currently thousands of Erchonia’s lasers are used daily to reduce body fat, eliminate pain, accelerate healing, and treat acne. For additional information, visit www.erchonia.com.
About Parker Seminars 
Parker Seminars is one of the world’s largest chiropractic seminar organizations. For more than 60 years, Parker Seminars has provided a place where health care professionals gather to learn, network, and share success tips. More than 45,000 people have attended Parker Seminars to date. Parker Seminars offers doctors of chiropractic, chiropractic assistants, and chiropractic students a wide variety of classes each seminar that provide practical business tools, patient communication skills, inspiring stories that provide rejuvenation, modern chiropractic wellness models, the latest in chiropractic and massage therapy technology, chiropractic and massage therapy industry news, and more. Parker Seminars holds an annual seminar in Las Vegas and has hosted seminars in Chicago, Cincinnati, Dallas, New Orleans, Montreal, Vancouver, Japan, Australia, and Rome. For additional information about Parker Seminars, visit the website at www.parkerseminars.com
Contact: Susan Woods, Crier Communications, 310-274-1072, susan@crierpr.com.

 

Erchonia Chooses Zerona Model for 2012 Marketing Campaign

Amber Pohl Wins Contest, a Trip to Miami and $5,000 cash

Erchonia, the global leader in low level laser healthcare applications, today announces a winner for its “Zerona Model Search” contest: 26-year-old Amber Pohl of Albuquerque, New Mexico.
Amber will be featured in Erchonia’s 2012 marketing campaign for the FDA-approved Zerona non-invasive, body contouring laser, will receive a cash prize of $5,000, and will also receive a four-night vacation for two to Miami, Florida. She will be photographed in a professional photo shoot and will be featured in Erchonia’s marketing campaign for one year.
Dr. Janice Moranz performed Amber’s non-invasive, painless Zerona treatments at her practice in Albuquerque. Amber lost a total of 8.85 inches of fat after six Zerona treatments, one forty-minute treatment every other day for two weeks.
 
“Because I could see the results of my Zerona treatment within the first week, it really motivated me to commit to a better diet and more exercise,”
says Amber. “Zerona was the jump-start I needed to get back into shape. I’m so excited I’ve won the chance to share my experience with other people who might need the encouragement. And I can’t wait to take my sister with me on my trip to Miami to celebrate!”
For more information, please visit www.myzerona.com. Follow Zerona on Twitter at www.Twitter.com/myzerona and on Facebook, www.Facebook.com/myzerona.
 
About Zerona
Using low level laser light, the Zerona laser creates a pore in fat cells and stimulates fat to leak out of the cell. The cell deflates, but is not destroyed, and the fat is naturally processed by the lymphatic system as waste. After six treatments, one every other day for two weeks, patients lose an average of 3.65 inches from their waists, hips and thighs without pain, side effects or downtime. Zerona was approved by the FDA for non-invasive circumferential reduction based on a recent double-blind, placebo-controlled, multi-site clinical trial.
 
About Erchonia
Erchonia is the global leader in low level laser healthcare applications. Over the last 15 years Erchonia has been conducting research and development with the world’s leading physicians to advance the science of low level lasers. Prior to market introduction, all Erchonia lasers are proven safe and effective through independent clinical trials. Currently thousands of Erchonia’s lasers are used daily to reduce body fat, eliminate pain, accelerate healing, and treat acne. For additional information, visit www.erchonia.com.
Susan Woods, Crier Communications, 310-274-1072 x 202 susan@crierpr.com

Erchonia Launches Zerona Model Search

Model Wins a Trip to Florida, $5,000 cash and Stars in Zerona’s 2012 Marketing Campaig

Erchonia, the global leader in low level laser healthcare applications, has launched a “Zerona Model Search” contest to find the next face—and body—of Erchonia’s 2012 marketing campaign for the FDA-approved Zerona non-invasive, painless, body contouring laser.

 

Erchonia is searching for someone who used the Zerona procedure to reduce inches from his or her waist, hips and thighs and would be interested in sharing the experience with others. Erchonia will award the winner a cash prize of $5,000, plus a four-night vacation to Miami, Florida, including airfare and hotel stay for two. The winner will also be photographed in a professional photo shoot and will be featured in Erchonia’s marketing campaign for one year.

 

To enter, visit Zerona’s Facebook page (www.Facebook.com/myzerona) to submit your name, address, phone number, a photo of you both before and after your Zerona procedure, what practice treated you, how many inches you lost with Zerona, and why you deserve to win. Submissions must be received by December 31, 2011.

 

“We’ve been so inspired by stories we’ve heard about how the Zerona procedure has really changed people’s lives, we thought this contest would be a fun way to learn more and reward people for accomplishing their goals,” says Charlie Shanks, vice president of Erchonia.

 

“Although we are only looking for someone who actually went through the Zerona procedure, the winner might not necessarily be the person who lost the most inches total. We are really interested in finding someone with a compelling story who encompasses the excitement, substance and sophistication of the brand,” adds Shanks.

 

Using low level laser light, the Zerona laser creates a pore in fat cells and stimulates fat to leak out of the cell. The cell deflates, but is not destroyed, and the fat is naturally processed by the lymphatic system as waste. After six treatments, one every other day for two weeks, patients lose an average of 3.65 inches from their waists, hips and thighs without pain, side effects or downtime. Zerona was approved by the FDA for non-invasive circumferential reduction based on a recent double-blind, placebo-controlled, multi-site clinical trial.

 

For more information, please visit www.myzerona.com. Follow Zerona on Twitter at www.Twitter.com/myzeronaand on Facebook, www.Facebook.com/myzerona.

 

About Erchonia

Erchonia is the global leader in low level laser healthcare applications. Over the last 15 years Erchonia has been conducting research and development with the world’s leading physicians to advance the science of low level lasers. Prior to market introduction, all Erchonia lasers are proven safe and effective through independent clinical trials. Currently thousands of Erchonia’s lasers are used daily to reduce body fat, eliminate pain, accelerate healing, and treat acne. For additional information, visitwww.erchonia.com.

 

Susan Woods, Crier Communications, 310-274-1072 x 202 susan@crierpr.com

Lose Love Handles with Zerona Laser myFOXla.com

Posted by: Tony Spearman / myFOXla.com
Los Angeles – The FDA just approved two non-surgical fat-reducing technologies that claim to contour the trouble spots with in as little as two weeks. The Zerona Laser is one of the technologies… It promises to get rid of love handles.
The Zerona’s low-energy lasers scan the problem areas creating tiny pores in the cell membranes and causing fat to seep out and cells to deflate or collapse.

Dermotologist Dr. Robert Seltzer says the non-invasive Zerona Lasers are cool to the skin, so there’s no topical anesthesia needed. In fact, he says the patient feels little to no pain, which means no downtime or recovery.Michael Brownlee has more on the procedure in this video report.

Watch Michael’s video report in the media player.
More Info:
Dr. Robert Seltzer
960 E Green St.
Pasadena, CA 91106
(626) 449-3830

FDA Grants Market Clearance for Erchonia’s Zerona Laser

FDA Grants Market Clearance for Erchonia’s Zerona Laser

Proven safe and effective for circumference reduction of the waist, hips and thighs

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.
 

About Erchonia

Erchonia is the global leader in low level laser healthcare applications. Over the last 15 years Erchonia has been conducting research & development with the world’s leading physicians to advance the science of low level lasers. Prior to market introduction, all Erchonia lasers are proven to be safe and effective through independent clinical trials. Currently thousands of Erchonia’s lasers are used daily to reduce body fat, eliminate pain, accelerate healing, and treat acne. For additional information, visit www.erchonia.com.
Contact:

Susan Woods | Crier Communications | 310.274.1072 x 202 | susan@crierpr.com

Erchonia Body Contouring Clinical Trial

Erchonia’s Body Contouring Clinical Trial Published in Lasers in Surgery and Medicine

Erchonia, the leading developer of non-invasive, low level laser healthcare applications, announces today the results of its body contouring clinical trial are being published in Lasers in Surgery and Medicine’s January issue.
Lasers in Surgery and Medicine, the most widely-circulated, peer-reviewed scientific journal dedicated to laser therapy and diagnosis, is publishing the complete results of Erchonia’s recent, double blind, randomized, multi-site and placebo-controlled study. The study revealed that in six treatments with Erchonia’s Zerona laser – without surgery, diet restrictions or any other adjuncts – patients lost an average of 3.65 inches from their waists, hips and thighs.

Results using the Erchonia laser also have been recently published in the Plastic and Reconstructive Surgery, The Aesthetic Surgery Journal, The American Academy of Cosmetic Surgery Journal, and Clinics in Plastic Surgery and Liposuction.

“With this study, Erchonia has set the standard for non-invasive body contouring devices,” comments Steve Shanks, president of Erchonia. “We have been researching the Erchonia laser’s effect on fat cells for about 12 years. This inclusion in the world’s most prestigious laser journal ads even more credibility to our proven science.”

In contrast to high-power, high-heat lasers that are used in various surgical procedures, Erchonia lasers produce a low-level, or cold, output that has no thermal effect on the body’s tissue. Instead, the non-invasive laser helps the body absorb fat by stimulating biological function. As fat congregates in interstitial spaces of cells for a certain amount of time, the Erchonia laser stimulates the body to rid itself of that excess fat using the body’s normal processes.

About the clinical trial: Placebo patients were treated with a 635nm L.E.D. The test group was treated with the Erchonia’s Zerona laser. All patients were treated six times over two weeks, for twenty minutes on each side of the body (forty minutes total). Patients were instructed not to restrict their diets. Patients did not feel pain during the non-invasive treatment, did not receive anesthesia, and assumed normal activities after each treatment.

Erchonia pre-submitted the study results to the FDA for comments and set the clinical significance as a reduction of a minimum of 3 inches cumulative of the waist, hips and thighs. The FDA wanted to distinguish between statistically significant and clinically meaningful results which it felt would help with consumer confidence. Erchonia also submitted a 20-patient study on lipid panel reductions during this treatment as a safety measurement. The results of this study will be published at a later date.

The article published in Lasers in Surgery and Medicine represents all of the data that Erchonia submitted to the FDA for market clearance or 510k which Erchonia expects is imminent.

About Erchonia
Erchonia is the global leader in low level laser healthcare applications. Over the last 15 years, Erchonia has been conducting research & development with the world’s leading physicians to advance the science of low level lasers. Prior to market introduction, all Erchonia lasers are proven to be safe and effective through independent clinical trials. Currently thousands of Erchonia’s lasers are used daily to reduce body fat, eliminate pain, accelerate healing, and treat acne. For additional information, visit www.erchonia.com

Contact: Katie Cycan, Crier Communications, 310-274-1072 x 207 katie@crierpr.com
Susan Woods, Crier Communications, 310-274-1072 x 202 susan@crierpr.com

Erchonia Opens Laser Healthcare Center at Parker College to Supplement Laser Class

Erchonia, the global leader in low level laser healthcare applications, in cooperation with Parker College of Chiropractic in Dallas, is proud to announce the opening of the new Erchonia Laser Center to provide better facilities and laser equipment for patient care, to increase public awareness, and to improve chiropractic education..Not only will students have the opportunity to learn about laser technology in this new class, but as interns they will gain invaluable real-world experience as they treat patients with Erchonia’s low level laser equipment in the new Erchonia Laser Healthcare Center. The first Erchonia Laser Healthcare Center in the country, the state-of-the-art facility offers the latest Erchonia technology along with a clinical setting for chiropractic interns to treat patients under the direction of qualified clinicians. Interns will experience first-hand how best to diagnose and treat patients’ ailments with Erchonia’s laser technology. The official ribbon cutting ceremony is scheduled for November 2nd at 1:00 p.m. at Parker College.
“Laser technology, more than ever before, has become indispensible for medical professionals,” comments Charlie Shanks, vice president of Erchonia Corporation.  “The academic training and the Erchonia Laser Healthcare Center will be significant resources for chiropractic students to get acquainted with our cutting-edge laser equipment and better serve their patients in the future.”
“We want our students to have the best education possible and that includes being proficient with laser technologies,” adds Dr. Ken Thomas, vice president of academics at Parker College. “The Erchonia Laser Healthcare Center and the academic class on laser technology provide the environment to explore and master this increasingly important field of study.”
 
About Erchonia
Erchonia is the global leader in low level laser healthcare applications. Over the last 15 years, Erchonia has been conducting research & development with the world’s leading physicians to advance the science of low level lasers. Prior to market introduction, all Erchonia lasers are proven to be safe and effective through independent clinical trials. Currently thousands of Erchonia’s lasers are used daily to reduce body fat, eliminate pain, accelerate healing, and treat acne. For additional information, visit www.erchonia.com
 
About Parker College of Chiropractic
Parker College of Chiropractic, located in Dallas, is one of the country’s leading educators of health care professionals with an international student enrollment. Founded in 1982, this private, nonprofit educational institution prepares men and women to become doctors of chiropractic. Parker College of Chiropractic is accredited by the Commission on Colleges of the Southern Association of Colleges and Schools to award the bachelor of science and doctor of chiropractic degrees. For additional information about Parker College of Chiropractic, visit the college’s website at www.parkercc.edu.
Contact: Katie Cycan, Crier Communications, 310-274-1072 x 207 katie@crierpr.com
Susan Woods, Crier Communications, 310-274-1072 x 202 susan@crierpr.com

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