Veincare

Veincare is a surgical diode laser system operating at 1470nm wavelength used to treat varicose veins and superficial venous reflux in the lower limbs. The system delivers laser energy through an optical fiber cable, with output power ranging from 0.5 to 15W, controlled via a foot switch and LCD panel interface.

The device is identical to its predicate in intended use, principle of operation, wavelength (1470nm), maximum power output (0.5-15W), pulse repetition (1-500Hz), pulse duration (0.2-800ms), and operational modes (CW, pulsed, group pulsed). The only documented changes are updated labeling and addition of a surgical optic fiber component.

IEC 60601-1:2005/(R)2012 and A1:2012 (medical electrical equipment general requirements), IEC 60601-1-6 Edition 3.1 2013, IEC 60601-2-22:2007/A:2012, IEC 60825-1 Edition 3.0 2014 (laser safety), and IEC 60601-1-2:2014/A1:2020 (electromagnetic compatibility).

Veincare is substantially equivalent because it shares identical intended use, design, function, and all technical specifications with predicate K241930. Both are manufactured by the same company and use the same laser module, power supply, and cooling system architecture. The optical fiber component received prior 510(k) clearance (K232106 and K241643), eliminating biocompatibility concerns. The labeling update and fiber addition represent modifications to the same fundamental laser surgical instrument without altering its core safety or performance characteristics.