Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The InMode Diolaze XL System is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime.
The InMode Diolaze XL System is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime.
The InMode Diolaze XL device is designed to deliver optical energy to the skin via a pre-cooled sapphire block. The good optical contact between the sapphire block and skin is achieved by using water based gel. The device provides individual adjustment of light fluence and pulse duration to achieve maximum efficiency and safety for each patient. The hand piece has integrated skin cooling to enhance safety and comfort of the treatment. The InMode Diolaze XL device consists of an AC/DC power supply unit, a diode driver, water cooling system, controller and a touch screen user interface. The 810nm diode laser hand piece is connected to the console via a cable and a foot switch activates the energy delivery to the hand piece. The hand piece comprises the InMode Diolaze XL with 20 diode laser bars stacked vertically. The diode is enclosed to the sapphire light guide. The diode laser produces up to 3000W peak optical power. Following are the InMode Diolaze XL device specifications: Laser Output Parameters: Wavelength Fluence Pulse width (duration) Light guide cooling Spot size 810 nm 5-40 J/cm2 5-200 ms (pulse type : Short/Long) Strong: 7ºC, Normal: 12ºC 11mm x27.5 mm Dimensions: 46cm W x 46cm D x 100cm H (18.2'' W x 18.2'' D x 40'' H) Weight: 32 Kg (70.548 lbs) Main Line Frequency (nominal): 50-60 Hz Input Voltage (nominal): 100-240 VAC
Summary parsed at:2026-06-01 05:59:57 UTC
