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.

DolorClast Radial

Plus90 Tip

EmBodyPlus (Tite) HP

EmBodyFx (Trim) HP

i-Forma Applicator applies RF energy through bipolar electrodes. The applicator has 2 RF electrodes, handle, cable, connector, and temperature sensors.

InMode RF Pro system with the non-invasive applicators employs RF energy for various applications:• i-Forma, Forma (Plus), Plus (Plus Plus) and Plus90 for relief of minor muscle aches and pain, relief of muscle spasm,and temporary improvement of local blood circulation.• WMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinklesand rhytids.• BodyFX™ (WMBody)/MiniFX™ for Relief of minor muscle aches and pain, relief of muscle spasm, temporaryimprovement of local blood circulation and temporary reduction in the appearance of cellulite.The InMode RF Pro System with the Fractional Applicators employs RF energy for various applications:• Fractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacingof the skin.• Fractora Applicator with 24 pins tip is intended for use in dermatological and general surgical procedures forelectrocoagulation and hemostasis.At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV• Morpheus8™ for dermatological and general surgical procedures for electrocoagulation and hemostasis.At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV

BodyFX

Firm

Contour Elite, Massager, therapeutic, electric

Contour Elite, Massager, therapeutic, electric

Massager, Therapeutic, Electric

Massager, Therapeutic, Electric

Massager, Therapeutic, Electric

Massager, Therapeutic, Electric

Massager, Therapeutic, Electric

Pulse Activation Therapy System

Equipment for the extracorporeal pneumatically operated ballistic pressure wave therapy.

Equipment for the extracorporeal pneumatically operated ballistic pressure wave therapy.

Equipment for the extracorporeal pneumatically operated ballistic pressure wave therapy.

Equipment for the extracorporeal pneumatically operated ballistic pressure wave therapy.

Equipment for the extracorporeal pneumatically operated ballistic pressure wave therapy.

The MASTERPULS® ONE is a compressed air-operated ballistic pressure wave generator.

Equipment for the extracorporeal induced shock and pressure wave therapy for stationary and mobile use.

Equipment for the extracorporeal induced shock and pressure wave therapy for stationary and mobile use.

Equipment for the extracorporeal induced shock and pressure wave therapy for stationary and mobile use.

Equipment for the extracorporeal induced shock and pressure wave therapy for stationary and mobile use.

Equipment for the extracorporeal induced shock and pressure wave therapy for stationary and mobile use.

Equipment for the extracorporeal induced shock and pressure wave therapy for stationary and mobile use.

Equipment for the extracorporeal induced shock and pressure wave therapy for stationary and mobile use.

Reaction™

ST Applicator

BC Applicator

FC Applicator

V10 Console

V-FORM

BC Small Applicator

BC Large Applicator

BC Medium Applicator

V20 Console