Purpose: Submental fat is a frequent aesthetic concern that can negatively affect quality of life. While low-level laser devices are FDA cleared for body circumference reduction, their use in the submental region has not been systematically studied. This study evaluated the safety and efficacy of a high-energy dual-wavelength low-level laser (405 nm violet, 520 nm green) for reducing visible submental fat.

Patients and Methods: This prospective, dual-center, open-label study incorporated blinded endpoint evaluation. Adults aged 18–65 years with measurable submental fat received eight non-contact treatments of 15 minutes each, delivered twice weekly over four weeks. The primary endpoint was the 12-week post-treatment responder rate, defined as correct identification of pre- versus post-treatment photographs by at least two of three independent board-certified cosmetic surgeons. Secondary endpoints included caliper-based submental skinfold thickness, participant satisfaction, and safety assessments.

Results: Thirty-one participants were enrolled; 30 were included in the intent-to-treat analysis and 24 in the perprotocol analysis. At 12 weeks post-treatment, the intent-to-treat responder rate was 86.7%, exceeding the predefined success threshold of 80%. In the per-protocol population, the responder rate was 95.8%. Mean submental skinfold thickness decreased by 5.45 mm. Participant satisfaction increased from 77% at week 4 to 92% at 12 weeks. No device-related adverse events occurred, and BMI remained stable.

Conclusion: A four-week regimen of eight non-contact treatments with a dual-wavelength low-level laser produced clinically meaningful and durable improvements in the appearance of submental fat with excellent safety and high patient satisfaction.