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.

H200 Wireless US System kit, Right Medium

H200 Wireless US System kit, Left Medium

H200 Wireless US System Kit, Right Large

H200 Wireless US System Kit, Left Large

H200 Wireless (US) Clinician Kit, Small / Medium

H200 Wireless US Clinician Kit Large

H200 Wireless US System kit, Right Small

H200 Wireless US System kit, Left Small

L300 Plus US System Kit, Left (regular)

L300 Plus US System Kit, Right (regular)

L300 Plus US Upgrade System Kit, Left (regular)

L300 Plus US Upgrade System Kit, Right (regular)

H200 Wireless US Clinician Upgrade Kit

The Vibratory Sensory Analyzer VSA-3000 is a computerized device for the quantitative assessment of large nerve fiber dysfunctions, designed for both clinical and advanced research applications. It measures the sensory threshold for vibration.The Device includes: main unit, at least one probe and accessories.

Ballancer® Gold is a massage system intended for use by people in good health. As noted above, Ballancer® Gold simulates the kneading and stroking action of manual massage by use of an inflatable garment that fills and deflates, applying a directional compress-and-release massage. This soothing massage action temporarily increases circulation in the areas to which the garment is applied, and temporarily relieves muscle aches and pain caused by fatigue or overexertion.

Ballancer® 505 V2 is a massage system intended for use by people in good health. As noted above, Ballancer® 505 V2 simulates the kneading and stroking action of manual massage by use of an inflatable garment that fills and deflates, applying a directional compress-and-release massage. This soothing massage action temporarily increases circulation in the areas to which the garment is applied, and temporarily relieves muscle aches and pain caused by fatigue or overexertion.

RPX® 2020 is a Massage System intended for use by people in good health. As noted above, RPX® 2020 simulates the kneading and stroking action of manual massage by use of an inflatable garment that fills and deflates, applying a directional compress-and-release massage. This soothing massage action temporarily increases circulation in the areas to which the garment is applied, and temporarily relieves muscle aches and pain caused by fatigue or overexertion.

RP Lite® is a massage system intended for use by people in good health.As noted above, RP Lite® simulates the kneading and stroking action of manual massage by use of an inflatable garment that fills and deflates, applying a directional compress-and-release massage. This soothing massage action temporarily increases circulation in the areas to which the garment is applied, and temporarily relieves muscle aches and pain caused by fatigue or overexertion.

Ballancer® 505 is a massage system intended for use by people in good health. As noted above, Ballancer® 505 simulates the kneading and stroking action of manual massage by use of an inflatable garment that fills and deflates, applying a directional compress-and-release massage. This soothing massage action temporarily increases circulation in the areas to which the garment is applied, and temporarily relieves muscle aches and pain caused by fatigue or overexertion

PainShield MD is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions including pain and soft tissue injuries. The low intensity and low frequency ultrasound energy is effective within a diameter of 20 cm and a depth of approximately 3 cm.

The Supplies kit includes a treatment actuator that incorporates an ultrasonic transducer and connects to the driver with a cable.The transducer is applied to the patient skin using single use adhesive pads. After connecting to the driver and activation, the actuator converts electric signals to ultrasound therapeutic waves.

PainShield MD Plus is intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions including pain and soft tissue injuries. The low intensity and low-frequency ultrasound energy is effective within a diameter of 20 cm and depth of approximately 3 cm.

The Supplies kit includes a treatment actuator that incorporates an ultrasonic transducer and connects to the driver with a cable. The transducer is applied to the patient skin using single-use adhesive pads. After connecting to the driver and activation, the actuator converts electric signals to ultrasound therapeutic waves.

The Reusable Patch is a small lightweight treatment patch, which is attached to the user's skin at the location of the pain. The patch is energized with a signal from the PainShield's driver and creates mechanical vibrations via piezo-electric element. After the use patch should be covered with its original liner till next use.

The Reusable Facial Patch is a small, lightweight treatment patch, which is attached to the user's skin at the location of the pain. The patch is energized with a signal from PainShield's driver and creates mechanical vibrations via the piezo-electric element. after the use patch should be covered with its original liner till next use.

PainShield MD applies ultrasound energy through a treatment patch that is placed at, or close to, the center of the painful area. The user may feel minor warmth at the treatment patch site during the treatment period. PainShield MD should be used under the prescription of a physician or physical therapist. PainShield MD is comprised of two elements: a treatment patch that contains the transducer, which delivers ultrasound waves and a portable battery-operated driver.