SurgiLight 1470 Diode Laser System (Model:Halo)

The SurgiLight 1470 Diode Laser System (Model: Halo) is a surgical laser device that uses a 1470 nm diode laser for vaporization, incision, excision, ablation, cutting, hemostasis, and coagulation of soft tissue. It is indicated for use in multiple surgical specialties including urology, thoracic surgery, plastic surgery, dermatology, ophthalmology, orthopedics, and others, including endovenous occlusion of the greater saphenous vein.

The device incorporates a 1470 nm gallium arsenide diode laser with a maximum therapeutic output of 12 W, operates in continuous wave and pulsed modes with pulse widths of 5–9,000 ms and repetition rates of 0.06–100 Hz, includes a red 650 nm aiming beam (<2.6 mW), and delivers laser energy via optical fiber with SMA905 connectors. It features a color LCD touchscreen interface, operates on AC power (100–240 V, 50/60 Hz, 6.5 A max) with an optional rechargeable lithium battery, and incorporates microprocessor control.

IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, and ANSI/AAMIES 60601-1. The device was tested per IEC 60601-2-22:2019 for surgical laser safety and performance, IEC 60601-1-2:2014+A1:2020 for electromagnetic compatibility, and IEC 60825-1:2014 for laser product safety.

The subject device uses identical 1470 nm diode laser technology at the same 12 W power output as predicate K240644, with the same indications for use and same regulatory classification (Class II, product code GEX). Both devices employ the same design principle—fiber-delivered diode laser with touchscreen control—meet the same consensus standards, and minor differences in aiming beam specifications (650 nm vs. 532 nm) and power supply design do not alter the basic mechanism of action, safety profile, or effectiveness. The technological and performance characteristics are substantially equivalent to the predicates.