Erchonia’s Low Level Laser Clinical Research
Erchonia works through an Investigational Review Board to ensure the protocol is acceptable to the FDA.
Clinical trials depending on their scope can take years to conduct. Erchonia Corporation makes this investment, as clinical trials are the foundational component of 510(k) submissions. Not all clinical trials result in market clearance by the FDA and not all FDA clearance is dependent on the submitter’s clinical data; however; Erchonia is committed to advance Laser Healthcare™ through sponsored clinical trials as doing so ensures the protocols are developed by Erchonia, making Erchonia and the physicians working on our behalf, the most knowledgeable to teach the protocol and making protocols themselves and intellectual assets, patentable. The following is a list of some of Erchonia’s clinical research.
1) Chronic Neck and Shoulder Pain/Low Level Laser — 2000 — Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study
a) First study done in support of 510(k) submission, second study requested by FDA
2) Chronic Neck and Shoulder Pain/Low Level Laser — 2001 — Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study
a)Study results used to obtain FDA clearance – K012580
b)To view NIH clinical trial records, click here.
3) Low Level Laser Light Therapy as an Aid to Liposuction and Reduction of Pain Associated With Surgery — 2004 — Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study
a) Study results used to obtain FDA clearance –K041139
b) To view NIH clinical trial records, click here.
4) Acne Vulgaris-Dermatological Conditions/Low Level Laser — 2005 — Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study
a) FDA clearance –K050672
5) Pain Associated with Breast Augmentation Surgery/Low Level Laser — 2007 — Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study
a) Results used to obtain FDA clearance – K072206
b) To view NIH clinical trial records, click here.
6) Non-Invasive Fat Reduction and Body Contouring –Laser Scanner Waist, Hips, and Thighs — 2009 — Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study
a) Study results used to obtain FDA clearance – K082609
b) To view NIH clinical trial records, click here
7) Equine Wound Healing – 2011— Sponsor, Case Study
a) Study completed from Nov. 2010-March 2011
b) Monitored by Hank Jann, DVM, MS, DACVS from Oklahoma State University
8) Equine Wound Healing – 2011 — Sponsor, placebo controlled, clinical study
a) Study completed from Feb. 2011-April 2011
b) Monitored by Hank Jann, DVM, MS, DAVCS from Oklahoma State University
9) Arm Circumference Reduction of the Upper Arms — 2011 — Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study
a) Study results used to obtain FDA clearance –K120257
b) Study submitted to be published 2012
c) To view NIH clinical trial records, click here.
10) Appearance of Cellulite (Verju Laser System) — 2012 — Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study
a) FDA clearance –K130922
b) Study submitted to be published 2013.
c) To view NIH clinical trial records, click here.
11) Non-Invasive Body Contouring Using GLS Laser – 532 nm (Green) Trade Name Verju — 2012 — Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study
a) FDA clearance –K123237
b) Study submitted to be published 2013.
c) To view NIH clinical trial records, click here.
12) Adjunct to Chronic Heel Pain Arising from Plantar Fasciitis Using the Erchonia FX635 Laser– 2012 — Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study
a) FDA clearance –K132940
b) Study results published in the American Orthopaedic Foot & Ankle Society April 2014
c) To view NIH clinical trial records, click here.
13)Non-Invasive Dermatological Aesthetic Treatment for Reduction of Circumference of Hips, Waist and Upper Abdomen When Applied to Individuals with a Body Mass Index (BMI) between 30 kg/m2 and 40 kg/m2–2013– Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study
a) FDA clearance –K142042
b) To view NIH clinical trial records, click here.
14) Non-Invasive Dermatological Aesthetic Treatment for the Reduction of Circumference of Hips, Waist and Thighs (Zerona-Z6 OTC)— 2012 — Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study
a) FDA clearance –K143007
b) To view NIH clinical trial records, click here.
15) Non-Invasive Dermatological Aesthetic Treatment for the Reduction of Circumference of Hips, Waist, Thighs and Upper Abdomen ~ 6 Week Treatment Protocol (Zerona-Z6)— 2014 — Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study
a) FDA clearance –K150446
b) To view NIH clinical trial records, click here.
16) Erchonia EVRL (EVRL)–2016
a. while using the red diode, for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin,
b. and while using the violet diode, to treat dermatological conditions, and specifically indicated to treat moderate inflammatory Acne Vulgaris.
a) FDA clearance – K152196
17) Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.) (Lunula Laser )— 2016 — Sponsor and Monitor, IRB approved, blind, placebo controlled, clinical study
a) FDA clearance –K153164
b) To view NIH clinical trial records, click here.
18) Non-invasive dermatological aesthetic treatment for the reduction of body circumference. (Zerona-Z6)— 2016
a) FDA clearance –K162578
19) Market Clearance to Treat Chronic Low Back Pain. (FX 635)— 2018 — Placebo-Controlled, Randomized, Double-Blind, Parallel-Group, Multi-Center clinical study
a) FDA clearance –K180197
b) To view NIH clinical trial records, click here.
20) Market Clearance for Relief of Chronic Musculoskeletal Pain (FX 635)— 2019 — A collection of Placebo-Controlled, Randomized, Double-Blind, Parallel-Group, Multi-Center clinical study
a) FDA clearance –K190572
Last Updated on August 31, 2020 by Erchonia
Additional Low Level Laser Therapy Studies
The Canadian Journal of Health Technologies – Low Level Laser Therapy For Lower Back Pain
Swiss DolorClast Method Clinical Research
Return to play after treating acute muscle injuries in elite football players with radial extracorporeal shock wave therapy
Background: To compare lay-off times achieved by treating acute muscle injuries in elite football players with a multimodal therapy approach that includes a specific protocol of almost daily radial extracorporeal shock wave therapy (rESWT) with corresponding data reported in the literature.
https://pubmed.ncbi.nlm.nih.gov/34876172/
Radial Extracorporeal Shock Wave Treatment (rESWT) of Myofascial Pain Syndrome in Low Back Pain
Myofascial Pain Syndromes – Low Back Pain – Lumbago
https://clinicaltrials.gov/ct2/show/NCT01835795
Radial Extracorporeal Shock Wave Treatment for Chronic Plantar Fasciopathy (RSWT_CPF)
https://clinicaltrials.gov/ct2/show/NCT02679521
A randomised, placebo controlled trial of low level laser therapy for activated Achilles tendinitis with microdialysis measurement of peritendinous prostaglandin E2 concentrations
Bjordal JM, Lopes-Martins RAB, Iversen VVA
British Journal of Sports Medicine 2006;40:76-80.
Radial extracorporeal shock wave therapy is safe and effective in the treatment of chronic recalcitrant plantar fasciitis: results of a confirmatory randomized placebo-controlled multicenter study.
Gerdesmeyer L, Frey C, Vester J, et al.
Am J Sports Med 2008;36:2100-2109
CLINICALLY PROVEN RESULTS: THE PEDro
30/45 of the randomized controlled trials (RCTs)2 on rESWT listed in the PEDro database, were performed with the Swiss DolorClast®
In 80% of these studies, the Swiss DolorClast® resulted in better clinical outcome than the control group
In the remaining 20% of these studies either not enough energy was applied or patients with indications not approved for the Swiss DolorClast® were included