Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)

The UTU series Medical Diode Laser is a portable surgical and therapeutic device for intra- and extra-oral dental procedures, including soft tissue incision, excision, hemostasis, coagulation, and vaporization. It also performs teeth whitening and provides low-level laser therapy for temporary pain relief. The device uses solid-state diode lasers (810nm, 980nm, 650nm, and 450nm wavelengths) with energy delivered via fiber optic handpiece, controlled by an LCD touchscreen interface and footswitch activation.

The device employs diode laser technology at wavelengths of 980±20nm, 810±10nm, 650nm±20nm, and 450nm±10nm with output powers ranging from 0.1W to 20W in continuous wave or pulsed mode (25μs–999ms pulse duration, 0.5Hz–20kHz repetition rate). It features a color touchscreen user interface, footswitch activation, fiber optic delivery system with surgical tips (200–400μm fiber diameter), and accessory tips for whitening, biostimulation, and therapy. The predicate devices use similar diode laser technology at comparable wavelengths and power levels with subtle differences that do not raise new safety or effectiveness concerns.

ISO 10993-1 (biological evaluation framework); ISO 10993-5 (in vitro cytotoxicity); ISO 10993-10 (skin sensitization); ISO 10993-23 (irritation); IEC 60601-1:2005+AMD1:2012+AMD2:2020 (medical electrical equipment safety); IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility); IEC 60825-1:2014 (laser product safety); IEC 60601-2-22:2019 (surgical laser equipment); IEC 80601-2-60:2019 (dental equipment).

The UTU device shares the same indications for use as the predicate D-Laser Blue/D-Laser 16 (K210367) across surgical, periodontal, whitening, and low-level laser therapy applications. It uses substantially similar diode laser technology at comparable wavelengths and power outputs; minor parameter differences do not introduce new safety or effectiveness questions for the stated indications. Although patient-contacting materials differ (aluminum alloy, acrylic, and glass versus stainless steel), biocompatibility testing per ISO 10993-5, 10993-10, and 10993-23 demonstrates compliance, and non-clinical testing confirms the device meets relevant electrical and laser safety standards, supporting substantial equivalence.