Manufacturer
Quanta System Spa585
Country / Region:Italy (IT)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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