Manufacturer
Inmode MD , Ltd.InMode Diolaze System
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K180719
- Device name
- InMode Diolaze System
- Company
- Inmode MD , Ltd.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2018-03-19
- Decision date
- 2018-06-14
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
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.
Intended Use
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.
Device Description
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
Predicate devices
3—
—
Not ingested
The MeDioStar NeXT Family
InMode Diolaze XL
K180719 references 3 predicate/reference devices
Cited as predicate
2Primelase Excellence
InMode Multi-system
2 submissions cite K180719 as a predicate
