Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The Sterling Supreme Diode Laser is indicated for dentistry and oral soft tissue procedures of: 1) The removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissues including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, frenectomy, gingivectomy, troughing, and removal of inflamed edematous tissue; 2) Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions; 3) Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.
The Sterling Supreme Diode Laser is indicated for dentistry and oral soft tissue procedures of: 1) The removal of lesions, excision, incision, vaporization, ablation, hemostasis, and photocoagulation on soft tissues including abscess treatment, contouring, curettage, sulcular debridement, pulpotomy, frenectomy, gingivectomy, troughing, and removal of inflamed edematous tissue; 2) Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions; 3) Light activation of bleaching materials for teeth whitening and laser-assisted whitening/bleaching of teeth.
The Sterling Supreme Diode Laser features a working beam output wavelength of 810±10 nm and output power ranging from 0.1 - 3.0 watts. The aiming beam output power is < 3mW with a wavelength of 650±20 nm. It utilizes an AlGaAs Diode laser source and is activated by a wireless foot pedal. The device has digital emission control with selectable fixed pulse durations and is cooled by a heatsink/fan. It operates on 100-240 VAC @ 47-63 Hz, 1.6A. The user interface is a color LCD touch screen, and the laser delivery system uses a sheathed quartz optical fiber. The handpiece design includes a stainless steel inner stem and a removable, sterilizable anodized aluminum outer sleeve. Patient contact articles are single-use disposable tips made of silica quartz, stainless steel, and ABS plastic.
Summary parsed at:2026-06-01 06:00:29 UTC
