Deka Bluebeam

The DEKA BlueBeam is a diode laser surgical instrument intended for incision, excision, vaporization, ablation, hemostasis, and coagulation of body soft tissue. It operates at 445 nanometers wavelength with adjustable power from 0.5W to 10W and can function in continuous wave, pulsed, or single-pulse modes.

The device is a Class 4 diode laser operating at 445nm wavelength with power output identical to the predicate (0.5W to 10W). Key differences include a slightly wider pulse duration range (1ms to 2s versus ≤4W: 1-45s and >4W: 1-60ms for the predicate), broader pulse frequency range (0.25-500Hz versus predicate's power-dependent limits), and a slightly lower aiming beam power (3.2mW versus ≤5mW). Spot size, operation modes, cooling method, and fiber/handpiece compatibility are substantially identical.

Electrical safety and EMC testing per ANSI AAMI ES60601-1:2005/(R)2012 with amendments, IEC 60601-1-2 Edition 4.1 (2020-09) for electromagnetic disturbances, IEC 60601-2-22:2019 for surgical laser equipment, and IEC 60825-1:2014 for laser product safety. Software verification and validation testing followed FDA guidance for device software functions.

The DEKA BlueBeam shares identical indications for use, regulatory classification, product code, laser type, power output range, wavelength, and laser class with the Wolf 445nm predicate device. Both devices use the same fiber and handpiece delivery systems with air cooling. The proposed device's pulse duration and frequency parameters are subsets or similar to the predicate's ranges, and all non-clinical testing per recognized laser and electrical safety standards demonstrates equivalent performance. No clinical data differences are identified between the devices.