Vi har 21st FDA 510K

Några intressanta kliniska studier

Det har pågått forskning sedan -50 talet på denna teknik, och det bolaget vi jobbar med, USA, har idag verksamhet i +80 länder och har varit forskningsledande sedan början av 2000-talet.

Pain Management

Evaluation of Low-Level Laser Therapy at 635nm for the Treatment of Acute and Chronic Neck and Shoulder Pain:  A Placebo-Controlled, Randomized Study
Laser in Surgery Medicine 2014, Volume 46, Number S25, March 2014 Ryan Maloney, Steven Shanks
Phoenix, AZ; Erchonia Corporation, McKinney, TX
Low-Level Laser Therapy for the Treatment of Chronic Neck and Shoulder Pain
Funct Neurol Rehabil Ergon 2016;6(2):97-104
Gregory C. Roche; Daniel J. Murphy; Trevor S. Berry; Steven Shanks
Effects of a Single Treatment with Two Non-Thermal Wavelengths on Chronic Neck and Shoulder Pain
Dove Press Journal, Medical Devices: Evidence and Research 2019:12 319–325
Robert G. Silverman, Albert Comey, Travis Sammons
A Randomized, Double-Blind, Sham-Controlled Study Evaluating the Effectiveness of a Low-level Laser Device for Treating Lower Back Pain
eMedical Research, Volume 2, Article ID: 100005
Trevor S. Berry, Paul J. Quarneri, Gregory Roche and Travis M. Sammons
Low-Level Laser Therapy for Treating Low Back Pain: 12-Month Follow-Up
Journal of Pain & Relief 2019, Volume 9, Issue 1
Trevor S. Berry, Paul J. Quarneri, Gregory Roche, and Travis M. Sammons
Low-Level Laser Therapy at 635 nm for Treatment of Chronic Plantar Fasciitis: A Placebo-Controlled, Randomized Study
Journal of Pain & Relief 2019, Volume 9, Issue 1
David M. Macias, Michael J. Coughlin, Kerry Zang, Faustin R. Stevens, James R. Jastifer, Jesse F. Doty
Two Randomized, Double Blind, Placebo-Controlled Trials Evaluating the Efficacy of Red 635nm Low Level Laser for the Treatment of Low Back Pain
The Journal of Foot & Ankle Surgery
Trevor S. Berry, Paul J. Quarneri, Travis M. Sammons, and Steve Shanks
Efficacy of 635nm Red Low-Level Laser on Nociceptive Musculoskeletal Pain Compared to NSAIDS, Opioids, and Other Light Sources
Orthopedics and Rheumatology Open Access Journal ISSN: 2471-6804
Jacob Januskewski, Chris Bromley, Cesar A Lara, Kirk Gair, Brandon Brock, Leonid Polishuk, and Travis Sammons
Low-Level Laser Therapy for the Treatment of Chronic Plantar Fasciitis
A Prospective Study

Foot & Ankle International
Volume 24. Number 4. April 2014
James R. Jastifer, MD, Fernanda Catena, MD, Jesse F. Doty, MD, Faustin Stevens, MD, Michael J. Coughlin, MD
Assessing the Impact of High Photon Energy Wavelengths on the Treatment of Chronic Neck and Shoulder Pain
Evidence-Based Complementary and Alternative Medicine, Volume 2023, Article ID 6672019, 9 pages
Travis Sammons, Kirk Gair, Robert G. Silverman, and Steve Shanks

Post Op

Low-Level Laser-Assisted Liposuction: A 2004 Clinical Study of its Effectiveness for Enhancing Ease of Liposuction Procedures and and Facilitating the Recovery Process for Patients Undergoing Thigh, Hip, and Stomach Contouring
Robert F. Jackson, MD; Gregory Roche, DO; Kimberly J. Butterwick, MD; Douglas D. Dedo, MD; Kevin T. Slattery, MD
Low-Level Laser-Assisted Liposuction: the Neira 4 L Technique
Clinics in Plastic Surgery
Rodrigo Neira, MD*, Luiz Toledo, MD, Jose Arroyave, BSc, MSc, TEM, SEM, Efrain Solarte, Dr, Rer, Nat, MSc, Carolina Isaza, MO, MSc, Oscar Gutierrez, MD, MSc, William Criollo, BSc, MSc, Hugo Ramirez, VMD, MSc, Maria I. Gutierrez, MD, MSc, PhD, Clara L. Ortiz-Neira, MD
**This article shows lasers effect on fat cells.

Low Level Laser in Liposuction Results
Low-Level Laser Therapy Effectiveness for Reducing Pain After Breast Augmentation American Journal of Cosmetic Surgery Vol. 26, No. 3, 2009
Robert F. Jackson, MD; Gregory Roche, DO; Todd Mangione, DO 

Onychomycosis

Erchonia Laser Therapy in the Treatment of Onychomycosis
A Preliminary Report on an Ongoing Clinical Trial

Podiatry Review Vol 71:2
Robert Sullivan and Deirdre O’Flynn
Clinical Director of Midleton Foot Clinic, Midleton, Ireland
Deirdre O’Flynn, Senior Associate, Midleton Foot Clinic

A Retrospective Study of Non-thermal Laser Therapy for the Treatment of Toenail Onychomycosis
Journal of Clinical and Aesthetic Dermatolgy
May 2017
Kerry Zang, DPM; Robert Sullivan, BSc (Hons) Podiatry, MSc Pod Surgery, PgCAcup, FIChPA, MInstChP; Steven Shanks
~Article available on JCAD online
Treatment of Toenail Onychomycosis using Laser Pharmacology
Arizona Institute of Footcare Physicians
Kerry Zang, Travis Sammons, Steve Shanks

Veterinary Medicine

Equine Wound Healing:  Influence Low Low Level Laser Therapy on an Equine Metacarpal Wound Healing Model
Henry W. Jann, *, Kenneth Bartels, Jerry W. Ritchey, Mark Payton, and John M. Bennett
Laser Therapy Haled Equine Leg Wounds Faster in Oklahoma State Study
by Lou Anne Epperley, DVM
Veterinary Practice News December 2012
Effects of Low-Level Laser Therapy on ROS Homeostasis and Expression of IGF-1 and TGF-1 in Skeletal Muscle During the Repair Process
Lasers in Medical Science
Mesenchymal Stem Cells Synergize with 635, 532, and 405 nm Laser Wavelengths in Renal Fibrosis
Photomedicine and Laser Surgery
Megan O’Connor, Rachana Patil,  Jiangzhou Yu, Richard Hickey, Kavitha Premanand, Andre Kajdacsy-Balla, Enrico Benedetti, and Amelia Bartholomew

The question of lasers’ exclusivity, as well as the degree of influence of special properties of low-intensity laser illumination (LILI)…

Researchers have discovered a molecular complex crucial for the transport of mitochondria within neurons, offering new insights into preventing…

While scientists have long assumed that the reactions of photosynthesis begin upon the absorption of just one photon, that hadn’t yet been…

The regular rise and fall of the sun resulted in the development of 24-h rhythms in virtually all organisms. In an evolutionary heartbeat, humans…

Although the COVID-19 pandemic was declared officially over on May 11, 2023, the original SARS-CoV-2 virus and new variants, such as EG.5…

Recent research has positioned the gut microbiota as an important susceptibility factor in Alzheimer’s disease by showing specific…

Chronic hepatitis B virus (HBV) infection is a serious global health concern, with an increased incidence and risk of developing cirrhosis and hepatocellular…

Nitric oxide (NO) is known to inhibit mitochondrial respiration reversibly. This study aimed at clarifying whether low level illumination…

Mechanisms of phototherapy of Alzheimer’s disease during sleep and wakefulness: the role of the meningeal lymphatics. With the increase…

Vad är ett FDA 510K

FDA är ett marknadsgodkännande från American Food and Drug Association. När det handlar om medtech så finns klassningen 510K, som vi har på vår teknologi. Det kallas för Golden standards, eller klass1.
Vad är då detta, och finns det någon relevans?
Ett FDA510K innebär att det som tillverkaren utfäster även stämmer, och att det är bevisat enligt följande premisser:
Dubbel blindad – varken läkare eller patient vet om det är placebo eller aktiv behandling.
Placebo – de kliniska studierna består av en grupp som får aktiv behandling, dvs laser, och en annan grupp får placebo dvs LED.
Randomiserad – deltagarna i de kliniska studierna är randomiserat utvalda, dvs läkare eller beställare av studien kan inte påverka vilka som deltager.
Multicentrerad – innebär att flera sjukhus är involverade i en studie, och är ovetande om vilka och hur många, detta innebär att resultat bör vara likvärdiga om de övriga stadierna följts enligt protokoll.