VIORA LTD VRE2001 ST Applicator

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.

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

Ventralight ST Mesh

FC Applicator

BC Applicator

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

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

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.

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

Ventralight ST Mesh