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585

Quanta System Spa

Country / region:Italy (IT)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Quanta System Spa
Italy (IT)

Product code

GEX
21 CFR 878.4810

Predicate devices

2
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Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K172198
Device name
585
Company
Quanta System Spa
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2017-07-21
Decision date
2017-10-17
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Vascular treatmentPigment treatment
Primary application
Vascular treatment
Classification source
AI classified

Indications for Use

The device is intended for treatment of benign vascular and benign pigmented lesions.

Intended Use

The device is intended for treatment of benign vascular and benign pigmented lesions.

Device Description

585 is a diode laser device used mainly for dermatology. It includes a main panel with the touch screen display, the optical fiber connector (SMA 905) and the status LEDs. On the rear panel the connectors for footswitch, remote interlock and power supply cable are located. The key switch and the emergency knob are located on the upper part of the device. The laser system is composed of an opto-mechanical block containing the laser source and heat dissipation system, aiming beam, control system and power electronics. The power electrical system is composed of a power supply. The control electronics, based on a microcontroller, manages power electronics, thermalization of the laser source and controls the user interface. Emission is triggered by means of a footswitch.

Summary parsed at:2026-06-01 06:00:36 UTC

Predicate devices

2

K172198 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K172198 as a predicate