The Alma Lasers Accent is a console with three previously cleared RF hand piecesand one ultrasound hand piece that is the subject of this submission. The previouslycleared hand pieces have not changed from what was cleared in their associated 510(k)submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with afrequency of 1 MHz using a 1.2 cm2 transducer. The touch screen on the console showsthe treatments that have been chosen and when the output is active.

The Alma Lasers Accent is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm2 transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active.

The Alma Lasers Accent is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm2 transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active.

The Alma Lasers Accent is a console with three previously cleared RF hand pieces and one ultrasound hand piece that is the subject of this submission. The previously cleared hand pieces have not changed from what was cleared in their associated 510(k) submissions. The new ultrasound hand piece is a therapeutic ultrasound hand piece with a frequency of 1 MHz using a 1.2 cm2 transducer. The touch screen on the console shows the treatments that have been chosen and when the output is active.

Opus Colibri 0.7mm Single-use Tip one ubit

Opus Colibri 1mm Single-use Tip one unit

Opus Colibri 1mm Single-use Tip Set of 6 units

Opus Colibri 0.7mm Single-use Tip Set of 6 units

Glide Disposable Tip Set of 12 units

Glide Disposable Tip one pc.

(includes Glide Disposable Tip Set (X12) & Opus Plasma Tip Kit)

APPLICATOR 2CM BLUE CALIBR

APPLICATOR 5CM BLUE CALIBR

APPLCTR 10CM GENSYS BLUE CALBR

APPLICATOR 5CM PRAXIS CALIBR

GEL CONDUCTOR 8.5OZ BOTTLE W/IFU

GEL CONDUCTIVE 5 LITER

APPLICATOR 2CM ASSY

APPLICATOR EXPORT 2CM ASSY

APPLICATOR EXPORT 10CM ASSY

CELLEBRA III is a therapeutic ultrasound micro controlled device in the frequencies of 1 MHz and 3 MHz, designed to be used for physiotherapy treatments.

CELLEBRA Compact 1MHz is a therapeutic ultrasound micro controlled device in the frequencies of 1 MHz, designed to be used for physiotherapy treatments.

CELLEBRA Compact 3MHz is a therapeutic ultrasound micro controlled device in the frequencies of 3 MHz, designed to be used for physiotherapy treatments.

CELLEBRA is a therapeutic ultrasound microcontrolled device in the frequencies of 1 MHz and 3 MHz, designed to be used for physiotherapy treatments.