Heager Medical Laser Family (Sabrina/Adolf)

The Heager Medical Laser Family is a dual-wavelength surgical laser system (980nm and 1470nm) that delivers laser light to soft tissue in contact and non-contact modes. The 980nm laser performs incision, excision, vaporization, ablation, hemostasis, and coagulation in otolaryngology, dental, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, and gynecology, including laser-assisted lipolysis. The 1470nm laser treats saphenous vein reflux associated with varicose veins.

The device features dual wavelengths (980nm±20nm at 20W and 1470nm±20nm at 15W), temperature monitoring, continuous/pulsed/single output modes, 0.1-10 second pulse duration, air cooling, fiber delivery system (600μm core, SMA905 connector), color LCD touch screen interface, and Class IV laser classification. Output power and wavelength tolerances are slightly broader than the predicate device (±20nm versus ±5-10nm), but the 1470nm power matches reference devices.

IEC 60601-1:2020 (medical electrical equipment general requirements), IEC 60601-1-2:2020 (electromagnetic disturbances), IEC 60601-2-22:2019 (surgical laser equipment), IEC 60825-1:2007 (laser product safety), and IEC 60601-1-6:2020 (collateral standard). The device complies with electrical safety and EMC standards equivalent to or more current than the predicate device.

The Heager device is substantially equivalent to predicate K212734 because both are dual-wavelength diode laser systems with identical intended uses, indications, and patient populations (adult surgical patients). Although wavelength tolerances are broader (±20nm vs ±5-10nm), the actual operating wavelengths (980nm and 1470nm) are identical. The 980nm maximum power (20W) is comparable to the predicate (16W), and 1470nm power (15W) matches reference devices. Pulse duration ranges are covered by reference devices K240179 and K082721. All identified gaps (wavelength tolerance, power supply, aiming beam specifications) do not create additional clinical risks. The device meets the same or more stringent safety standards (IEC 60601-1:2020 versus 2005) as the predicate.