Samtliga studier som ligger till grund för FDA-godkännande är dubbel blandade, placebo kontrollerade och multi-site, dvs den mest trovärdiga metoden som finns på marknaden.
Nedan är listat kliniska studier samt utkomst.
Att notera, Emerald är den senaste i serien, och flertalet kliniska studier är utförda på föregångare, men som fungerar med samma mekanism.
Notera även att det finns ca 7500 studier publicerade på PubMed gällande effektiviteten av LLLT. Nedan är endast ett axplock av de specifika studier som finns på vår teknologi och i detta fall fettreduktion.
1) Non-Invasive Dermatological Aesthetic Treatment for the Reduction of Body Circumference in Individuals With a Body Mass Index (BMI) of up to 40 kg / m² – 2019 – The data used to get this approval combined all previous data Erchonia® had on 20-40 BMI patients in the green laser studies below.
2) Non-Invasive Dermatological Aesthetic Treatment for the Reduction of Body Circumference — 2016.
FDA-clearance – K162578
3) Non-Invasive Dermatological Aesthetic Treatment for the Reduction of Circumference of Hips, Waist, Thighs and Upper Abdomen — 6 Week Treatment Protocol — 2014 — Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
FDA-clearance – K150446
To view NIH clinical trial records, click here.
4) Non-Invasive Dermatological Aesthetic Treatment for the Reduction of Circumference of Hips, Waist and Thighs — 2012 — Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
FDA-clearance – K143007
To view NIH clinical trial records, click here.
5) 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.
FDA-clearance – K142042
To view NIH clinical trial records, click here.
6) 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.
FDA-clearance – K123237
To view NIH clinical trial records, click here.
7) Appearance of Cellulite (Verju Laser System) — 2012 — Sponsor and Monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
FDA-clearance – K130922
To view NIH clinical trial records, click here.
