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

26% moderate, and none as severe. Mild reported events in the individual studies were; Site 1 (17/19, 89%) and at Site 2 (14/23, 61%). For the entire study, 26% of events were reported as moderate. Moderate reported events in the individual studies were; Site 1 (2/19, 11%) and at Site 2 (9/23, 39%). No events were reported as severe.There was one instance of erythema that resolved within a day. Mild tenderness (n=26) and edema (n=3) were commonly seen, resolving with 4-7 days. Occasional ecchymosis (n=2) was mild and resolved within 12 days. Occasional palpable firmness (n=10) resolved within 55 to 69 days except in one case (present at 3-month follow-up visit as a subtle finding on careful exam and absent at 6 month follow-up visit). There were no reports of blistering, pinpoint bleeding, crusting, scabbing, itching, pustules, skin burns, scarring, infection, allergic reaction, hypopigmentation, and hyperpigmentation.

Hypothermic and hyperthermic-induced adipocyte injury elicits an inflammatory response. Human and animal histological findings indicate that precisely applied thermal injury triggers apoptosis of the adipocytes, inducing an inflammatory response resulting in mobilization of macrophages.^4,7 The injured and dead adipocytes are engulfed and digested by macrophages, and in the ensuing weeks to months the injured adipocytes are removed through the inflammatory process.^8-10 Much of the evidence for the thermally induced inflammatory response comes from studies of cryolipolysis where reduction in subcutaneous fat is accomplished without injury to adjacent tissues, and the induced inflammatory response has no effect on serum lipid profiles or liver tests.¹¹ A hypothermic action decreases subcutaneous tissue temperature below body temperature and maintains it for prolonged period of time (tens of minutes).12 The amount of temperature decrease to achieve efficacy is greater than 30oCHyperthermic treatment increases adipose tissue temperature to 42-47°C for sustained time, also resulting in adipocyte injury and eliciting an inflammatory response.⁴ The amount of temperature increase to achieve this target temperature is less than 10oC. The amount of tissue damage can be quantified from the relationship between exposure time and tissue temperature.¹³ At moderate increase in temperature to 6ºC above normal (ie, 43ºC), the structural integrity of the lipid bilayer is lost and at 45ºC for more than 5 minutes cell membranes show damage.^4,14,15 The injured adipocytes are removed through body inflammatory processes.^4-6 Previous studies with this 1060 nm diode laser prototype established the ability of prolonged exposure of subcutaneous tissue