Clinical Evaluation of the Safety and Efficacy of a 1060-nm Diode Laser for Non-Invasive Fat Reduction of the Abdomen

Background: Despite the proven efficacy of liposuction, there is a population of patients who prefer non-surgical alternatives. Laser hyperthermia-induced lipolysis has emerged as one non-invasive alternative to liposuction. Objectives: The authors sought to evaluate the safety and efficacy of a 1060-nm (±10 nm) diode laser for non-invasive fat reduction of the abdomen. Methods: This single-arm, 2-center study enrolled 30 patients. Patients received a 25-minute 1060-nm diode laser treatment on their abdomen. Ultrasound adipose measurements, body weight, and circumference were taken at baseline and at 6- and 12-week follow-up visits. Blinded evaluators identified "before"and "after"photos of each patient. A patient satisfaction questionnaire was completed by each patient at study exit. Results: A total 29 patients completed all treatment and follow-up visits. Ultrasound images showed an adipose reduction of 8.55% at 12 weeks post-treatment (P < 0.0001). Blinded evaluators correctly identified 67% of the pre- and post-treatment images at site 01 (Sacramento, CA) and 56% at site 02 (Dallas, TX). Satisfaction was high, with 72% of patients reporting being either "satisfied"or "very satisfied"with their results on a 5-point Likert scale. Pain was rated as mild by 62% of patients, moderate by 38%, and severe by none on the Wong-Baker Scale. Conclusions: These results indicate that a single treatment with a 1060-nm (±10 nm) diode laser, per the treatment protocol, is safe and effective in reducing unwanted fat in the abdomen as objectively measured employing ultrasound. The treatment was well-tolerated among all patients, with minimal discomfort reported and high patient satisfaction. Level of Evidence: 4:.