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The AOC Phase II 50 surgical diode laser system has the same general intended use as the predicate diode lasers. This intended use includes incision, excision, coagulation and vaporization applications in the following surgical specialties: - Urology Gynecology Gastroenterology Pulmonology General and Thoracic Surgery Neurosurgery (hemostasis) Ear, Nose, and Throat; Head/Neck Surgery Dermatology/Plastic Surgery No new intended use was sought in this Premarket Notification.

The AOC Medical Systems Model Phase II 50 Fiber-Coupled Diode Laser System delivers up to fifty (50) or sixty (60) watts of CW optical power from a compact, air cooled unit. It is a complete, self-contained instrument, including a high efficiency power supply, an adjustable light output with constant current operation and a visible aiming laser. The system couples the laser light into high numerical aperture delivery fibers fitted with standard SMA-905 fiber connectors. The diode lasers in this unit were fabricated by Applied Optronics Corp. from single quantum well, strained-layer, indium gallium aluminum on gallium arsenide semiconductor material. The diode lasers are sealed in a rugged, factory-aligned, environmentally protective module. High electrical efficiency of the diode lasers eliminate the need for water cooling and assure low maintenance, reliable laser operation for this allsolid-state system. Each individual diode laser emits at a narrow wavelength; however coupling several diodes through a fiber optic bundle results in each diode wavelength contributing to a broader spectrum emitted form the final delivery fiber. The laser energy is centered at 980nm with a total range from approximately 970-1000 nm. For the 60 watt version, premium, high-efficient diode laser components are selected in constructing the laser module and the output display is adjusted accordingly. The AOC Phase II 50 has a modular design comprised of: Laser Diode and Cooling Module containing the laser diodes, the heat sink and fans. Optics Module containing a beamsplitter pick-off for display of the total optical power. Front panel for simple control of the unit. Transformer isolated power supplies and control electronics. Unique attributes of this system include the following: Multiple, individually fiber-coupled, high power diode lasers mounted on a large thermal footprint to allow sustained high power CW operation without water cooling. Optical power level continuously adjustable from the front panel, with display of optical output power. Low power, visible aiming laser for beam targeting prior to activation of the high power lasers. The aiming laser is controlled independently of the high power lasers. Immediate turn-on capability. No warm-up period. No system alignments or maintenance to be made by the user. Forced air cooling (no water). Maximum inlet air temperature 30° C. Individually replaceable, fiber pigtailed diode lasers. Repairs performed at factory. The microprocessor controlled AOC Phase II 50 diode laser system is designed to allow easy and safe operation of the laser using controls common to other surgical laser systems. The laser system utilizes a menu driven set-up operation for user prompts and program entry. The laser can be set for continuous output or programmed for single or repeat pulses at output powers up to 50 or 60 watts depending on the unit specified. A footswitch or handswitch, activated by the user, always controls laser output. An optional remote control for use in a sterile plastic dressing (e.g., standard OR microscope drape) allows the user to change the power and activate Ready and Standby Modes

The AOC Phase II 25 surgical diode laser system has the same general intended use as the predicate diode lasers. This intended use includes incision, excision, coagulation and vaporization applications in the following surgical specialties: Urology Gynecology Gastroenterology Pulmonology General and Thoracic Surgery Neurosurgery (hemostasis) Ear, Nose, and Throat; Head/Neck Surgery Dermatology/Plastic Surgery No new intended use was sought in this Premarket Notification.

The AOC Medical Systems Model Phase II 25 Fiber-Coupled Diode Laser System delivers up to 25 watts of CW optical power from a compact, air cooled unit. It is a complete, self-contained instrument, including a high efficiency power supply, an adjustable light output with constant current operation and a visible aiming laser. The system couples the laser light into high numerical aperture delivery fibers fitted with standard SMA-905 fiber connectors. The diode lasers in this unit were fabricated by Applied Optronics Corp. from single quantum well, strained-layer, indium gallium aluminum on gallium arsenide semiconductor material. The diode lasers are sealed in a rugged, factory-aligned, environmentally protective module. High electrical efficiency of the diode lasers eliminate the need for water cooling and assure low maintenance, reliable laser operation for this allsolid-state system. Each individual diode laser emits at a narrow wavelength; however coupling several diodes through a fiber optic bundle results in each diode wavelength contributing to a broader spectrum emitted form the final delivery fiber. The laser energy is centered at 980nm with a total range from approximately 970-1000nm. The AOC Phase II 25 has a modular design comprised of: Laser Diode and Cooling Module containing the laser diodes, the heat sink and fans. Optics Module containing a beamsplitter pick-off for display of the total optical power. Front panel for simple control of the unit. Transformer isolated power supplies and control electronics. Unique attributes of this system include the following: Multiple, individually fiber-coupled, high power diode lasers mounted on a large thermal footprint to allow sustained high power CW operation without water cooling. Optical power level continuously adjustable from the front panel, with display of optical output power. Low power, visible aiming laser for beam targeting prior to activation of the high power lasers. The aiming laser is controlled independently of the high power lasers. Immediate turn-on capability. No warm-up period. No system alignments or maintenance to be made by the user. Forced air cooling (no water). Maximum inlet air temperature 30° C. Individually replaceable, fiber pigtailed diode lasers. Repairs performed at factory. The microprocessor controlled AOC Phase II 25 diode laser system is designed to allow easy and safe operation of the laser using controls common to other surgical laser systems. The laser system utilizes a menu driven set-up operation for user prompts and program entry. The laser can be set for continuous output or programmed for single or repeat pulses at output powers up to 25 watts. A footswitch or handswitch, activated by the user, always controls laser output. An optional remote control for use in a sterile plastic dressing (e.g., standard OR microscope drape) allows the user to change the power and activate Ready and Standby Modes. The following pre-packaged, presterilzed disposable optical fibers are available for use with the AOC Phase II 25 laser system: | Fiber Model | Type | |----------------|----------------------------------------------------------------| | AOC DCLF-600 | 600um Conical tip | | AOC DCLF-1000 | 1000um Conical tip | | AOC DCLF-600B | 600um Hemispherical Ball tip | | AOC DCLF-1000B | 1000um Hemispherical Ball tip | | AOC DBLF-60S | 600um Side firing | | AOC DBLF-100S | 1000um Side firing | | AOC DBLF-60SF | 600um Scatter Free Side firing | | AOC DBLF-60 | 600um Free Beam | | AOC Neos | Conical (conical shaped) | | AOC Neos | Delta (wedge shaped) Handpiece, Laparoscopic<br>and Bare Fiber | | AOC HSD | Conical shaped with electrode |