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.

To be used with Tixel C MSTX0002 Model

To be used with Tixel C Model MSTX0002

Standard Handpiece used with TXLD0002

Handpiece used with Tixel System TXLD0002

Tixel Back Unit

Sterilization Case

Sterilization Tray for ParallelPortal Instrumentation

Sterilization Tray for Laparoscopes

Sterilization Tray for Bariatric Laparoscopes

Sterilization Tray for Articulating Laparoscope

Sterilization Tray for Urology/Gynecology Accessories, Single Tier

Sterilization Tray for Urology/Gynecology Instruments, Two Tier

Sterilization Tray for Autoclavable Camera

Small Acorn

Large Acorn

Trocar, Pyramidal Tip

Trocar, Pyramidal Tip

Trocar, Pyramidal Tip

Obturator for Hasson Cannula

Obturator for Hasson Cannula

Cannula, Automatic Valve, Stopcock, without Trocar.

Cannula, Automatic Valve, Stopcock, without Trocar.

Hasson Cannula, Automatic Valve, Stopcock

Hasson Cannula, Automatic Valve, Stopcock

Fixable Cone for Hasson Cannula.

Reducer Sleeve, 12.5/11.0 mm to 5.5 mm

Male Luer Lock for 6 mm Tubing

Female Luer Lock for 6 mm Tubing

Sterilization Tray for Laparoscopic Instruments

Sterilization Tray for 45 cm Laparoscopic Instruments

Electrosurgical Probe, Spatula-tip

Electrosurgical Probe, J-Tip

Electrosurgical Probe, L-Tip

Electrosurgical Probe, Needle-tip

Outer Sheath Replacement

Sterilization Tray for Suction Irrigator Tips

Intradiscal Adaptor Cable

Parallel Bipolar Adapter Cable

RF Hand Controller

Interventional Spine Generator

Adapter for Davol Nezhat/Dorsey Suction/Irrigation Probes with Three O-Rings