Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The InMode Diolaze XL System with the Diolaze XL 810nm Hand piece 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 target population includes subjects seeking hair removal.
The InMode Diolaze XL System with the Diolaze XL 810nm Hand piece 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 multisystem (manufactured by InMode MD Ltd.) is a laser based technology platform system utilizing different hand pieces for laser hair removal procedures. The Diolaze XL system is designed to deliver optical energy to the skin via a pre-cooled sapphire block. The device provides individual adjustment of light fluence and pulse duration to achieve maximum efficiency and safety for each patient. The handpiece has integrated skin cooling to enhance safety and comfort of the treatment. The InMode Diolaze XL System consists of an AC/DC power supply unit, a diode driver, water cooling system, controller and a touch screen user interface. The 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 System with 20 diode laser bars stacked vertically. The diode laser produces up to 3000W peak optical power. The InMode Diolaze XL System utilizes three add-ons diode laser hand pieces: Diolaze 810nm Hand piece, Diolaze 755/810nm Hand piece, and Diolaze 810/1064nm Hand piece.
Summary parsed at:2026-06-01 05:57:22 UTC
