Quanta System Youlaser Prime

Youlaser Prime is Quanta System's resurfacing and surgical laser. It pairs a 10,600 nm CO2 source with a 1550 nm fiber laser. The FDA cleared the family under K241092 on October 10, 2024. Three models are covered: Youlaser PRIME MT, Youlaser PRIME, and the CO2-only Youlaser PRIME CO2. The 510(k) summary describes an RF-driven sealed CO2 tube of up to 50 W, running in continuous and pulsed modes, and a 1550 nm fiber laser of up to 15 W. Both are delivered through an articulated arm to a handpiece or scanner. The summary lists a weight of 130 kg.

Quanta describes the Prime as running the second generation of its Quanta Mixed Technology. That technology combines the two lasers in variable proportions in modes Quanta calls MIX, Hybrid and MIX-Hybrid. The CO2 side adds a high peak power HyperPulse mode. The console has a 13.3 inch display. The OptiScan PRIME scanner has its own touchscreen for choosing pattern, shape and size, and uses a plug and play connector. Quanta also lists new surgical handpieces with spots from 150 microns to 2 mm.

The Prime follows earlier Youlaser generations. Quanta's history page dates the first mixed Youlaser, the Youlaser MT, to 2013. The Youlaser CO2, a 30 W system cleared under K182669, served as one of the Prime's predicates. Within the Prime family, the label tells you whether a unit has both sources or only CO2. On a PRIME CO2, no 1550 nm or mixed modes appear on the screen.

When selling a Youlaser Prime, state the exact model from the label and say whether the OptiScan PRIME scanner and its tips are included. List the surgical handpieces as well. Buyers will ask about the condition of the arm and scanner, the software version, the service history of the CO2 tube and the fiber laser, and any error codes the unit has shown.