Search Results

The device is intended to be used in surgical, aesthetic 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 without maintenance when measured at 6, 9 and 12 months.

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 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.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, sample size, ground truth establishment, or multi-reader multi-case studies. The document is an FDA 510(k) clearance letter and summary for a laser device, primarily focusing on its equivalence to predicate devices based on technical specifications and non-clinical testing for safety and effectiveness according to established standards. It does not include the detailed clinical study information you requested.

Ask a specific question about this device