FDA cleared indications for 2940nm and 1470nm on JOULE Platform K0600033 2940 nm Indications for Use: The Profile Multi-Platform Systems and Accessories are designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage,… mucous membrane, …organs and glands. Surgical specialties and applications include general surgery, plastic surgery, aesthetic surgery, dermatology, urology, gynecology, genitourinary,… . General Surgery: The Er: YAG is intended for the surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, tissue ablation and/or vessel coagulation. Genitourinary/Urology: Genitourinary surgery of soft tissue, including: treatment of bladder, urethral and ureteral tumors; superficial urinary bladder tumors; invasive bladder carcinomas; urethral and penile hemangioma; urethral strictures; lesions of the external genitalia; condylomas; bladder neck obstructions. Gynecology: Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condylomas. K101916 1470 nm Indications for Use: The JOULE 1470 nm Multi-Platform Systems and delivery accessories are intended for delivery of laser light to soft tissue for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities. The JOULE 1470 nm Multi-Platform Systems with ProFractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue. 2940 nm Indications for Use: The JOULE 2940 nm Multi-Platform Systems with delivery accessories are designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Aesthetic Surgery: Skin resurfacing and treatment of wrinkles. Dermatology & Plastic Surgery: Indications include epidermal nevi, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, and decubitus ulcers. It is also used for laser assisted site preparation for hair transplantation. The JOULE 2940 nm Multi-Platform Systems with ProFractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing, and ablation and coagulation of soft tissue. K180508 The Joule 2940 nm ProFractional System with its accessories is intended for 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 cheilitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars).
