Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
Coagulation, resurfacing and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, benign pigmented lesions, and vascular dyschromia. Use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars).
Coagulation, resurfacing and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, benign pigmented lesions, and vascular dyschromia. Use in soft tissue (skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes; organs, and glands) such as, but not limited to: Dermatology and plastic Surgery: Skin resurfacing Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars).
The JOULE 2940 nm ProFractional System is a laser device intended for use in soft tissue procedures. It utilizes a 2940 nm Er:YAG laser and features an articulated arm delivery system. The system includes a microprocessor control system, a water to air cooling system, and an energy monitor that displays energy delivered to tissue. The device operates with a maximum repetition rate of up to 3 Hz and has a pulse duration ranging from 0.5 to 1.5 msec. The spot size can vary from 1.3x1.3mm to 20x20mm, and it can deliver energy up to 70 mJ/microbeam.
Summary parsed at:2026-06-01 05:57:13 UTC
