Diode Laser System model Dawn-S

The Diode Laser System model Dawn-S is a dual-wavelength surgical laser (980nm and 1470nm) designed for incision, excision, ablation, vaporization, and coagulation of soft tissues. It is indicated for use across multiple surgical specialties including general surgery, dermatology, ENT, urology, gynecology, and others, with the 1470nm wavelength specifically approved for endoscopic applications and treatment of superficial vein reflux.

The device operates at 980nm (15W) and 1470nm (15W) wavelengths with continuous or pulsed modes, adjustable pulse duration (10-990ms), 650nm red aiming beam, 8-inch color touch screen interface, fiber delivery system, and air cooling. These specifications are identical or substantially similar to three predicate devices (K212734, K240747, K240644), differing only minimally in 980nm power output (1W lower than one predicate) and compliance with updated IEC standards.

IEC 60601-1:2020 (medical electrical equipment general requirements), IEC 60601-1-2:2020 (electromagnetic compatibility), IEC 60825-1:2007 (laser safety), and IEC 60601-2-22:2012 (surgical laser equipment requirements). The device complies with the latest consolidated versions of these standards, though predicates used older editions.

The Dawn-S is substantially equivalent because it uses identical diode laser technology with the same dual wavelengths (980nm and 1470nm), identical indications for use across all surgical specialties, nearly identical performance parameters (power outputs within 1W variation), and identical operational modes and delivery methods as the three predicate devices. Non-clinical testing demonstrates compliance with the same consensus standards, and the minor variations in power and standard versions do not raise new safety or effectiveness concerns compared to legally marketed predicates.