InMode VLaze

Inmode MD , Ltd.

Country / region:Israel (IL)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Israel (IL)

Product code

GEX
21 CFR 878.4810

Predicate devices

3

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K173677
Device name
InMode VLaze
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

K173677 references 3 predicate/reference devices

Cited as predicate

1

1 submission cite K173677 as a predicate