Sinclair Elysion Pro

The Elysion Pro is a diode laser hair removal system made by High Technology Products S.L.U., the Barcelona company that trades as Cocoon Medical. Sinclair bought Cocoon Medical in April 2021. FDA cleared the elysion-pro under K193367 with a decision in March 2020, and its GUDID entry describes it as the ELYSION diode laser hair removal system under catalog number 522040. The cleared uses are permanent reduction in hair regrowth in static and dynamic modes and treatment of pseudofolliculitis barbae on Fitzpatrick skin types I to VI.

The console is a central control unit with three removable applicators. Each applicator holds its own AlGaAs diode array, so the light source lives in the handpiece. Two applicators emit at 810 nm with treatment windows of 10 by 10 mm and 18 by 10 mm, and the third emits at 755 nm through a 10 by 10 mm window. A sapphire contact window is held at 5 degrees C. Pulse duration runs from 3 to 400 ms, static mode fires at up to 3 Hz and dynamic mode at 5 to 15 Hz.

Sellers sometimes confuse the Elysion Pro with the Primelase from the same factory. FDA used the Primelase Excellence as a predicate for the Elysion, but the Primelase has five applicators and spots up to 30 by 17 mm, while the Elysion Pro has three applicators and a largest window of 18 by 10 mm. A MedWrench listing for the Elysion-Pro also mentions a combined 810, 940 and 1060 nm setting that is not part of the US clearance, so units sold outside the US may carry a different applicator set.

Before an offer, a buyer wants to know how many applicators are included and which wavelength each one is, since each is a separate diode assembly. Report chips on the sapphire windows, whether the tips reach temperature, the console label, error messages and service records.