Venus Concept Venus Epileve

The Venus Epileve is a tabletop diode laser for hair removal, cleared by the FDA under K200786 on June 9, 2020. It emits at a nominal 800 nm, within a band of 785 to 815 nm. The clearance covers hair removal, permanent hair reduction and treatment of pseudofolliculitis barbae across all Fitzpatrick skin types, including tanned skin.

The 510(k) summary describes a console that holds the power supply, laser diode driver, controller, touchscreen and a closed water cooling loop with a pump. One detachable applicator connects at the back of the console and rests in a cradle on top. The diode array sits inside the applicator and fires through a sapphire light guide in an anodized aluminum shell, chilled by a thermoelectric cooler to between 5 and 15 degrees Celsius. There is only one spot size, 2.0 cm2 (16.5 by 12 mm). The filing lists up to 80 J per pulse, 4 to 40 J/cm2, pulse durations of 5 to 170 ms, a Slide mode up to 10 Hz, a Pulse mode up to 3 Hz and 1600 W of peak power.

The FDA used the Venus Velocity as the predicate, and the two share wavelength, pulse duration range and both operating modes. The Velocity is a floor standing console with three interchangeable tips of 1.69, 3.5 and 7.0 cm2 and 2400 W of peak power. A tabletop unit with a single fixed light guide is an Epileve.

Before an offer, a buyer will look for chips or scratches on the sapphire guide, confirm that the cooling loop reaches temperature without leaks or alarms, and test the trigger, footswitch and emergency stop. The system uses user login and password protection, so plan to hand over working credentials. Include the footswitch, goggles, water filling kit, service history and photos of the serial label and the main screen.