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The SURGIMEDICS®/TMP® Vision Cardioplegia Delivery System is intended to mix, cool, warm, and deliver oxygenated blood cardioplegia solution during cardiopulmonary bypass.

The Vision Cardioplegia Delivery System is intended for mixing, cooling, warming, and delivery of oxygenated blood cardioplegia solution during cardiopulmonary bypass.

The Diomed Surgical Diode Laser is intended for use in delivering 15, 30, or 60 Watts of continuous wave radiation to a flexible optical fiber, for use in ablation, incision, excision, coagulation, and vaporization of soft tissue in open and endoscopic surgical procedures.

The Diomed Surgical Diode Laser is a Class IV GaAlAs (Gallium Arsenide) diode laser with a wavelength of 805nm and a visible (aiming beam) 5 milliwatt Class Illa diode laser with a wavelength of 650nm. The Diomed 15/30/60 Watt Surgical Diode Lasers are modifications to the maximum power output rating of the original Diomed 25 Watt Diode Surgical Laser. The modifications are in three areas: Labeling: The Diomed 25 Surgical Diode Laser will be renamed (relabeled) to the Diomed 30 Surgical Diode Laser. This change is being made to be consistent with the industry practice of designating a laser's power based on the output power at the laser port rather that at the tissue site. There is no change in construction or performance of this device. Power Output: Two additional models will be created by doubling and halving the output power to produce the Diomed 15 15W Surgical Diode Laser and the Diomed 60 60W Surgical Diode Laser, respectively. The same basic design is retained. The 15 Watt model uses eight 2 Watt laser diodes, the 30 Watt model uses sixteen 2 Watt laser diodes, and the 60 Watt model uses sixteen 4 Watt laser diodes. The power supply and cooling designs of the new models have been appropriately scaled, while the mechanical design and user interface remain unchanged. Indication For Use: The indications for the three models are expanded to include both contact and non-contact use for the following soft tissue applications: - · General Surgery - · Ophthalmology/Oculoplastic - · Urology - · Gastroenterology - · Gynecology - · Otorhinolaryngology - · Pulmonary/Thoracic - · Dermatology/Plastic Surgery - · Neurosurgery (coagulation only) - · Orthopedic