Manufacturer
Quanta System SpaEcho
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
- K232236
- Device name
- Echo
- Company
- Quanta System Spa
- 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
2LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity
MeDioStar
K232236 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K232236 as a predicate
