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Ablation, incision, excision, coagulation and vaporisation of soft tissues in the following open and endoscopic surgical procedures: General Surgery, Ophthalmology/Oculoplastic, Urology, Gastroenterology, Gynecology, Otorhinolaryngology, Pulmonary/Thoracic, Dermatology/Plastic Surgery, Neurosurgery (coagulation only), Orthopedic

The Diomed Delta 25 Laser consists of a Class IV InGaAs/A1GaAs laser diode with a wavelength of 1064nm ± 20 nm and a visible laser (aiming beam) of 5 milliwatt Class IIIa diode laser with a wavelength of 635 - 655 nm. The Diomed Delta 25 is a diode laser capable of delivering up to 25 W of continuous wave or pulsed radiation via an optical fiber coupled to the laser aperture.

The Diomed Delta 15 and Diomed Delta 30 Lasers are intended for use in delivering up to 15 or up to 30 Watts, respectively, of continuous wave or pulsed radiation to a flexible optical fiber or spot handpiece for use in ablation, incision, excision, coagulation and vaporisation of soft tissues in open and endoscopic surgical procedures, including EndoVenous Laser Treatment (EVLT). Indications For Use: - General Surgery . - Ophthalmology/Oculoplastic . - Urology . - Gastroenterology . - Gynecology . - Otorhinolaryngology . - Pulmonary/Thoracic . - Dermatology/Plastic Surgery . - Neurosurgery (coagulation only) . - Orthopedic . - Treatment of varicose veins and varicosities with superficial reflux of the Greater ● Saphenous Vein. - Treatment of incompetent refluxing veins in the superficial venous system in the lower limb

The purpose of this Special 510(k) is to notify FDA of the proposed new Diòmed Delta 15 and Diomed Delta 30 Lasers, which are equivalent replacements for the Diomed 15plus and 30plus. Like their predecessors, the Diomed Delta 15 and Diomed Delta 30 Lasers consist of a Class IV GaAlAs (Gallium Aluminium Arsenide) diode laser with a wavelength of 810 ± 20 nm and a visible light (aiming beam) 5 milliwatt Class IIIa diode laser with a wavelength of 635 - 655 nm. The Diomed Delta 15 and Diomed Delta 30 Lasers are made up of a treatment laser and aiming beam. The Diomed Delta 15 is a diode laser capable of delivering up to 119 J/cm² of pulsed radiation via a fiber optic hand piece or 15 W of continuous wave radiation via an optical fiber coupled to the laser aperture. The Diomed Delta 30 is a diode laser capable of delivering up to 400 J/cm2 of pulsed radiation via a fiber optic hand piece or 30 W of continuous wave radiation via an optical fiber coupled to the laser aperture.

Diomed 810 nm Surgical Lasers and EVLT Procedure Kit are intended for use in endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

Diomed 810 nm Surgical Lasers and EVLT Procedure Kit is a semiconductor diode lasers operating at 810 ± 20 microns and associated disposables.