Echo

Quanta System Spa

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

Product code GEX· 21 CFR 878.4810

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Company

Italy (IT)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K232236
Device name
Echo
Country / region
Italy(IT)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2023-07-27
Decision date
2023-10-20
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Hair removalVascular treatmentOther
Primary application
Hair removal
Classification source
AI classified

Indications for Use

The device is intended to be used in surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery and dermatology, including:
- Treatment of benign vascular lesions
- Hair removal
- Permanent* hair reduction
* permanent hair reduction defined as reduced hair growth with or without maintenance when measured at 6, 9 and 12 months.

Intended Use

The device is intended to be used in surgical, aesthetic and cosmetic applications in the medical specialties of general and plastic surgery and dermatology, including: - Treatment of benign vascular lesions - Hair removal - Permanent* hair reduction * permanent hair reduction defined as reduced hair growth with or without maintenance when measured at 6, 9 and 12 months.

Device Description

The laser device Echo is a 160 W diode laser emitting at 808 nm laser wavelength. The device is a therapeutic and aesthetic medical laser system for professional use only. For the release of laser radiation to the patient, the device uses, as delivery system, a fiber with a handpiece plugged on its end. Echo is a transportable mobile electrical equipment with a display with a graphical user interface (GUI) for user-device interaction. Laser radiation is delivered through optical fibers connected to handpieces having fix spot dimension. The device is equipped with an integrated skin cooler. In this case, a specific housing called Skin Cooler handpiece is provided to provide skin cooling and housing the laser handpiece at the same time. Laser emission can be activated by the footswitch or by a finger-switch placed on Skin Cooler handpieces.

Summary parsed at:2026-06-01 05:33:18 UTC

Predicate devices

2

K232236 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 K232236 as a predicate