Manufacturer
Inmode MD , Ltd.InMode VLaze
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
- K173677
- Device name
- InMode VLaze
- Company
- Inmode MD , Ltd.
- Country / Region
- Israel(IL)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2017-11-30
- Decision date
- 2018-02-23
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Vascular treatment
- Primary application
- Vascular treatment
- Classification source
- AI classified
Indications for Use
The InMode VLaze is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.
Intended Use
The InMode VLaze is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.
Device Description
The InMode VLaze device is designed to deliver diode laser 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 VLaze device 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 VLaze device laser with linear scanning system, cooled sapphire output window (3 x 4mm2), and electronic shutter. The sapphire light guide is located on the front tip of the hand piece and delivers the laser beam energy to the treated tissue, while cooling the skin. The pair of thermoelectric coolers (TECs) located on both sides of the sapphire block provide cooling to a temperature of 7oC. The hand piece contains a trigger button which starts the laser scan and radiation. Fluence is delivered within the limits of 40 to 300J/cm2. The hand piece has a cable that is 170cm long and connects the hand piece to the console via a connector. InMode VLaze Device Specifications: Wavelengths Fluence Pulse width (duration) Light guide cooling Spot size 1060nm ± 15nm 40 - 300 J/cm2 5-100msec Strong :7oC, Normal:12 oC 3mm x 4mm Dimension 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 05:56:37 UTC
Predicate devices
3—
—
Not ingested
EVO platform
InMode Diolaze XL
K173677 references 3 predicate/reference devices
Cited as predicate
1InMode Multi-system
1 submission cite K173677 as a predicate
