An Evaluation of the Effect of the Erchonia Laser for Non-invasive Reduction of Submental Fat

An Evaluation of the Effect of the Erchonia Corporation CFL Laser for Non-invasive Reduction of Submental Fat

The purpose of this clinical study is to determine the effectiveness of the Erchonia® CFL (manufactured by Erchonia Corporation (the Company), in providing noninvasive fat reduction in the submental area.

This clinical study is a prospective open-label design with post-study independent blinded outcome analysis to evaluate the efficacy of the Erchonia® CFL Laser in providing a noninvasive fat reduction in the submental area. Participants will receive 8 treatments over the course of 4 weeks.

Inclusion Criteria:

• Male or female 18 to 65 years of age, inclusive.

• Submental and submandibular skin fold thickness > 1cm (measured by caliper).

• Subject agrees to maintain his/her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study.

• Subject agrees to abstain from partaking in any treatment to promote body contouring and/or weight loss during the course of study participation. Such treatments include, but are not limited to:

  • over-the-counter and/or prescription medications; dietary/herbal supplements and appetite suppressants.
  • weight loss programs/diet plans.
  • surgical procedures for sculpting of the chin fat pad/weight loss, e.g. submental lipectomy, lap bands.

• Subject has signed a written informed consent form.

Exclusion Criteria:

• Evidence of any cause of enlargement in the submental area other than localized subcutaneous fat, such as swollen lymph nodes or ptotic submandibular glands.
• Treatment with dermal fillers, radiofrequency or laser procedures, or chemical peels in the neck or chin area (below the mandible) within the past 6 months.
• Botulinum toxin or other aesthetic drug injections within the neck or chin area (below the mandible) within the past 6 months.
• History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.) or implant in or adjacent to the area of intended treatment.
• Any dermatological conditions, such as scars in the location of the treatment area that may interfere with the treatment or evaluation.
• Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
• Pregnant or intending to become pregnant in the next 6 months.
• Currently enrolled in a clinical study of an unapproved investigational drug or device.