Manufacturer
Inmode MD , Ltd.InMode Diolaze XL
Country / Region:Israel (IL)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
- K170738
- Device name
- InMode Diolaze XL
- Company
- Inmode MD , Ltd.
- Country / Region
- Israel(IL)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2017-03-10
- Decision date
- 2017-08-07
- 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 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.
Intended Use
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.
Device Description
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
Predicate devices
1LightSheer Desire Light Laser System
K170738 references 1 predicate/reference device
Cited as predicate
2InMode VLaze
InMode Diolaze System
2 submissions cite K170738 as a predicate
