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The Clinicon SureLase CO2 Laser System is intended for use in laser surgery procedures for incision, excision, vaporization, ablation, coagulation, or cauterization in specialties such as: general surgery, cosmetic surgery, dermatology, gynecology, head & neck surgery, neurosurgery, oral surgery, otorhinolaryngology, pediatric surgery, plastic & reconstructive surgery, podiatry, and urology.

The Clinicon SureLase laser system is a mobile platform that utilizes a radio frequency (RF) excited carbon dioxide (CO2) laser tube to produce an infrared beam at a nominal 10.6 µm wavelength at powers adjustable from 2 to 20 Watts Continuous Wave (CVV). Laser energy is conducted to the point of application by a flexible fiber waveguide and handpiece / tip assembly. Laser system operation is controlled by operator input on a touch-screen display panel. The RF laser drive is modulated to provide additional pulsed and superpulse emission modes selected from the laser system control panel.

The CO2 Laser, Model C-LAS is intended to be used by physicians for soft tissue cutting and tissue ablation in the following specialties: - Cosmetic Surgery . - Dermatology . - General Surgery . - Gynecology . - Head & Neck Surgery . - Neurosurgery . - Oral Surgery . - Orthopedic Surgery ● - Otorhinolaryngology t - Pediatric Surgery ● - Plastic & Reconstructive Surgery t - Podiatry - Urology

The CO2 Laser System, Model C-LAS is an easily transported table top laser console made of mainly machined aluminum and optics for the transmission of reflection of CO2 laser wave lengths. It is a carbon dioxide laser which emits laser light at 10.6 micrometers and has a RF excited laser tube which produces an output power of about 30 watts. The laser is for used by physicians for cutting and coagulation at a wound during surgery. The physician uses the laser light on tissue via lenses and a focusing hand piece, or via a diamond scalpel which transmits the laser light onto the scalpel.

The intended use of the Clinicon WaveGuide Platform is to deliver carbon dioxide laser energy from a CO2 laser source to a CO2 laser accessory, with minimal beam degradation. The waveguide platform can be used with various manufacturers' CO2 lasers and laser accessories, including Clinicon accessories. The specific indications are dependent upon the cleared indications for use of the laser system and laser accessories to which the waveguide platform is attached. The Clinicon Interconnect enables Luxar accessories that are designed to be used with the standard Luxar cables to be connected with the Clinicon WaveGuide Platform.

The Clinicon WaveGuide Platform (K992472, SureGuide CO2 Laser Beam Delivery System now marketed as Clinicon WaveGuide Platform) is an accessory for CO2 laser systems. Its two primary components are a laser system interface adapter and a fiber cable assembly consisting of a hollow silica fiber having an internal coating that reflects and propagates CO2 laser energy and a flexible protective outer cover. The WaveGuide CO2 Fiber Cable has FSMA 905 series fiber optic connectors on each end and may be used with CO2 laser systems that provide such connectors between the laser system and various beam delivery accessories. The Clinicon Interconnect (Distal Adapter) is an accessory to the WaveGuide Platform that duplicates the termination end & laser beam characteristics of the Standard Luxar Fiber. This allows Luxar accessories to be attached to the WaveGuide Platform and used in the same manner.

The Clinicon UHP/disposable tip is/are indicated for use in general and plastic surgery, neurosurgery, ophthalmology, oral surgery, oto-mino-laryngology, podiatry, gynecology, and urology procedures for incision, excision, vaporization, ablation, coagulation, cauterization of soft tissue. The Clinicon UHP/disposable tip indications are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached.

The Universal WaveGuide Handpiece comes in two designs, one that accepts 1.5 mm O.D. size fiber tips and one that accepts 2.5 mm O.D. size fiber tips. The 1.5 mm handpiece is used with the Free Beam and Flexible fiber tips. The 2.5 mm handpiece is used with the rigid fiber tips. The collet component determines the O.D. size fibers that can be inserted into the handpiece. The nozzle and tip lock collet secures the fiber and prevents twisting of the fiber tip. The hand piece is attached to the Clinicon WaveGuide Platform by the FSMA connector at the distal end of the waveguide. The Fiber Tips are made of the same proprietary waveguide fiber as the Clinicon WaveGuide Platform, described in the premarket notification, K992472, SUREGUIDE CO2 Laser Beam Delivery System. The waveguide fiber is inserted into a straight or curved stainless steel sheath for the 2.5 mm O.D. rigid fiber tips or into a Teflon tube for the 1.5 mm O.D. flexible fiber tips. The fiber tips, both rigid and flexible are of various lengths for use in various surgical procedures. The rigid fiber tips are also of various degrees of curvature and certain tips may have a contact probe tip cover made of Teflon. The fiber tips are disposable, single-use devices, and both the rigid and flexible fiber tips have a section of colored polyethylene at the distal end of the fiber cable that acts as a depth gauge to assure the fiber is completely seated in the handpiece. The colored polyethylene also acts as a sterilizer indicator that will render the tips unusable if they are re-sterilized by distorting the polyethylene and preventing the fiber from being inserted into the handpiece.

The SureGuide CO2 Laser Beam Delivery System is intended for use with CO2 laser systems for general and plastic surgery procedures, neurosurgery, ophthalmology, oral surgery, oto-rhino-laryngology, podiatry, gynecology, and urology procedures for incision, excision, vaporization, ablation, coagulation, and cauterization of soft tissue. Refer to the laser system Directions for Use manual for specific indications for Use. The SureGuide CO2 Laser Beam Delivery System is indicated for use in general and plastic surgery, neurosurgery, ophthalmology, oral surgery, otorhino-laryngology, podiatry, gynecology, and urology procedures for incision, excision, vaporization, ablation, coagulation, and cauterization of soft tissue. The specific SureGuide CO2 Laser Beam Delivery System indications are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached.

The SureGuide CO2 Laser Beam Delivery System is an accessory for CO2 laser systems. Its two primary components are a laser system interface adapter and a fiber cable assembly consisting of a hollow silica fiber having an internal coating that reflects and propagates CO2 laser energy and a flexible protective outer cover. The SureGuide CO2 Fiber Cable has FSMA 905 series fiber optic connectors on each end and may be used with CO2 laser systems that provide such connectors between the laser system and various beam delivery accessories. The laser adapter design is derived from the Medical Optics laser system flexible cable assembly interface adapter and has a section designed to fit the Luxar LX-20 mast interface. Beam alignment and focus optics are built into the interface adapter to allow correction of inherent beam alignment variations between laser systems and provides optimization of laser beam coupling into the SureGuide.

The Diamond LaserKnife™ is indicated for incision and/or excision, with or without cauterization/coagulation, of soft tissue in open dental, dermatology, general and plastic surgery, neurosurgery, ophthalmology, oral surgery, oto-rhino-laryngology, podiatry, and urological procedures. Refer to the laser system Directions for Use manual for specific indications for Use.

The Diamond LaserKnife ™ is an accessory hand piece for CO2 laser systems, that consists of a diamond cutting blade and handle coupled to a flexible fiber guide cable that conducts CO2 laser energy to the blade tip. The laser energy is emitted from the facets at the blade tip to the tissue when the laser is energized.

For use in vaporization, incision and excision of soft tissue in dermatology, general surgery, neurosurgery, oral surgery, oto-rhino-laryngology, and podiatry.

The Clinicon C4 CO2 laser is a sealed, liquid and convection cooled carbon dioxide surgical laser that is DC excited. The output of the laser is a concentrated beam of invisible infrared light at 10.6 micrometer wavelength. The laser has an output power range of 0-25 watts delivered to tissue. The laser system is fitted with a surgical hand piece as a standard accessory, producing a collimated beam with a spot size of 200 microns. The hand piece is manufactured from 304 surgical stainless steel.

Wavelength range 430-1064 Nanometer In this wavelength range, SureScan is designed to assist in the partial or full coagulation or denaturization of a variety of benign epidermal vascular and pigmented lesions where precise dosimetry is required to minimize damage to adjacent or underlying tissue layers. SureScan use is restricted for adaptation to those lasers that have received FDA clearance for applications in cutaneous laser surgery for the treatment of benign superficial vascular and pigmented lesions such as port wine stains angiomas, telangiectasia, café-au-lait marks, age spots, lentigines, tattoos and similar conditions. Wavelength range 1440-10640 Nanometer In this wavelength range. SureScan is designed to assist in a variety of procedures that require the ablation of soft tissue, where precise removal is required to minimize damage to adjacent or underlying tissue layers. SureScan use is restricted for adaptation to those lasers that have received FDA clearance for soft tissue ablation, such as scars, keloids, warts, skin malformations and similar conditions.

SureScan adapts to laser systems with wavelengths in the visible spectrum from 430nm to 700nm ( blue, green, yellow and red ) and to lasers in the invisible spectrum from 755nm to 2940nm to deliver precise amounts of energy to tissue. SureScan comes equipped with multiple treatment patterns in multiple sizes. SureScan is programmable to enable adjustment of scan speed across tissue to ensure uniform laser absorption or ablation which significantly reduces thermal damage and thus the potential for post operative scarring. SureScan also has an adjustable spot overlap density and scanner dwell time feature which allows the surgeon to select individual treatment parameters most suitable for various tissue types and lesions. SureScan employs a microprocessor controlled, mirror system for scanning the laser beam. SureScan juxtaposes laser beam spots with precisely controlled timing and predetermined amounts of space in between or with spatial overlap of these spots. Depending on the type of laser used and its wavelength, highly controlled tissue coagulation or ablation is achieved with minimal thermal injury. SureScan's operation is controlled via an existing laser foot switch, to eliminate any adjustment of the internal electronics or workings of the laser. To ensure precise transmission of the laser beam through the SureScan device and subsequent safe delivery of laser energy to tissue, a user controlled adjustment feature allows for realignment of the laser beam due to a misaligned fiber or other delivery system as it is directed through the SureScan hand piece. As a result, the operator is always assured of optimum beam quality without 'clipping', as the laser beam exits the SureScan hand piece. Different sized squares, rectangles, triangles, hexagons, parallelograms and lines may be selected and are outlined by the laser systems pilot laser. These various patterns are then automatically covered by the therapeutic laser and coagulate, denaturize or ablate tissue in a single scan cycle. This results in a more predictable and controlled tissue effect to optimize treatment results.

SureScan may be used for a variety of soft tissue ablation procedures where precise removal is required to minimize damage to adjacent or underlying tissue layers.

SureScan converts any CO2 laser, pulsed or CW, into a sophisticated aesthetic surgery laser system for performing a wide variety of laser procedures. It comes equipped with six different patterns in 26 different sizes. It automatically adjusts the scan speed to ensure uniform laser ablation which eliminates charring and thermal damage. The collimated beam ensures constant power density and tissue removal at any working distance. The SureScan has an adjustable spot overlap density for more precision and control. The Scan outline and size are clearly displayed on the tissue, allowing precise placement of the laser energy and subsequent scan shapes.