THE FDA-CLEARED, ISO 13485:2003, ISO 9000-CERTIFIED PILOT VETERINARY DIODE LASER SYSTEM FDA 510(k) Number: K100143

The 9W Pilot Laser is unique in the marketplace in that it can be used to perform a wide variety of procedures, namely surgical, therapeutic, dental and acupuncture in both the animal and human markets, where other lasers are limited to either surgical-only or therapeutic-only uses. In addition, the unique, patented optical fiber management system allows you to maintain a constant power output for the life of the laser something no other diode laser is capable of doing! The Pilot Laser is manufactured in Salt Lake City, UT by CAO Group, Inc. (CAO) under the direction of Dr. Densen Cao, PhD. CAO offers design, development, manufacturing, marketing and sales of innovative medical, dental, veterinary, forensic, and solid state lighting products. CAO Group is headquartered in the Salt Lake City, Utah area with research, development, and manufacturing facilities in both West Jordan, Utah and Langfang (Beijing) China. All facilities are FDA registered and ISO 9000/EN 13485 certified. CAO Group is the largest diode laser manufacturer in the world, with over 10,000 units manufactured and sold. Below is listed some of the benefits of the Pilot laser: BENEFITS OF THE PILOT LASER IN VETERINARY SURGERY: Surgical Uses - Pilot Laser for Soft Tissue Procedures: Providing an alternative to traditional surgery, Pilot surgical hand-pieces handle similarly to a scalpel and are extremely effective for common soft-tissue procedures. In contrast to electro-surgery devices that cannot be used for dental, optical, and/or orthopedic surgery involving implants, the Pilot laser can be safely used in each of these procedures: Ophthalmologic applications (glaucoma laser surgery) Dental and oral surgery applications Declawing (relatively blood-free and pain-free) Neutering and spaying Mass and tumor removal Biopsy Transitional cell carcinoma (bladder cancer) surgery Orthopedic surgery Soft palate surgery Stenotic (pinched) nostrils resection Eyelid surgery, and more Endoscopic Surgery - Laser Assisted Endoscopic Surgery for Minimally Invasive Procedures: In contrast to CO2 lasers, the Pilot laser can be used for endoscopic surgery since its laser light travels through a 400-micron silica fiber that can be inserted into endoscopic equipment. This allows the diode laser to reach sites where a CO2 laser cannot reach, resulting in a wider range of surgical procedures and options. Benefits include rapid recovery, less trauma and pain, reduced need for anesthesia, and minimal blood loss. Laser-Assisted Arthroscopy: Minimally invasive camera-assisted surgery in joints, bursa, or tendon sheaths. It is used to remove bone chips, treat OCD, or to address joint or tendon sheath infections. It is also used as a diagnostic tool in areas that cannot be seen with any other imaging modality, such as damage to the cruciate ligaments, menisci, or articular cartilage of the stifle. Laser-Assisted Laparoscopy:

Laparoscopy utilizes camera-assisted technology to provide minimally invasive surgery in the thorax or abdomen regions, such as removal of intra-abdominal cryptorchid, testicles, or ovaries. It minimizes the pain associated with the procedure, decreases the chances of post-operative complications, and allows a faster healing time Benefits to the Surgeon: Multiple surgical capabilities: Laser surgery improves many surgical procedures by making them simpler and reducing risk; this enables surgeries that are not practical with conventional methods. Enhanced visibility of the surgical field: The laser light seals capillaries and small blood vessels as it cuts, thereby dramatically reducing bleeding. This results in a much clearer and drier surgical site. Increased precision and control: The focal spot size of the beam may be adjusted down to a small fraction of a millimeter or expanded for a much wider coverage. The laser power may be set for rapid removal of relatively large tissue amounts, or adjusted to remove only one cell layer at a time. Reduction of surgery time: The hemostatic effect of the laser beam and the improved visibility of the surgical field often reduce the duration of the surgery. Benefits to the Patient: Less Pain: The animal feels less pain after laser surgery because laser surgery seals the nerve endings as it "cuts". Less Bleeding: Since the laser seals small blood vessels during surgery, it can reduce the amount of time required for surgery and anesthesia, thereby reducing the risk of complications. Less Swelling: The laser can precisely remove diseased or unhealthy tissue without being as invasive to surrounding healthy tissue as in traditional surgery Reduced Risk of Infection: Lasers offer a reduced risk of infection because they seal the skin as they cut, thereby reducing the chance of bacterial infection Quicker Recovery: Because there is less pain, bleeding, and swelling with laser surgery, this leads to quicker recovery than with traditional surgery. BENEFITS OF THE PILOTLASER IN DENTAL SURGERY AND OTHER DENTAL PROCEDURES: The Pilot Laser is used for treating many Oran and dental conditions, including: Gingivitis Periodontal Disease Post-Surgical Oral Pain Hard and Soft Tissue Debridement and Contouring Dental Surgery Deciduous Tooth Extraction Broken Tooth Extraction Root Canal Treatment Removal of Gingival Hyperplasia and Epulides Gingival Tissue Procedures in Esthetic Dentistry Laser-Assisted Gingivectomy Wound Healing of Periodontal Pockets Oral Soft Tissue Management Periodontitis is a relatively common disease; various therapies have been recommended for its treatment, which includes nonsurgical, antimicrobial, and surgical therapy; in recent years, lasers have been used for all the three above-mentioned purposes with great success. BENEFITS OF PILOT LASER THERAPY PROCEDURES: Reduces recovery time from injury and illness Does not mask symptoms but corrects muscle-related problems by directly treating them Enhances performance without medication and inherent side-effects

 Alleviates pain and soreness from strenuous activity Reduces stress levels, both physical and psychological Improves respiratory, digestive, immune, and neural systems Increases venal and lymphatic circulation Prevents additional injury (saving money, as well as pain and trauma to the animal) Ultimately improves the animals quality of life Treatment for Specific and Non-Specific Disorders: Acute & Chronic Otitis Hip Dysplasia Anal Glands Common Geriatric-Related Conditions Hot Spots Dermatological Disorders Lick Granulomas Cystitis Sinusitis Rhinitis Stomatitis Soft Tissue Injuries Muscle Strains & Tears Sore Muscles & Joints Degenerative Joint Conditions Tendon & Ligament Injuries Invertebral Disc Disease Osteoarthritis Healing of Muscle Sprains & Ruptures Overall Pain & General Malaise Neurological Pain Peripheral Neuropathy Chronic, Non-Healing Wounds Pre & Post-Operative Treatment Anti-Inflammatory Treatment Vasodilation, Improved Blood Circulation Anti-inflammatory Treatment NEEDLE-FREE PILOT LASER ACUPUNCTURE The World Association of Laser Therapy (W.A.L.T.) has determined that acupuncture points can be stimulated by photobiostimulation (Laser Acupuncture), a painless and sterile acupuncture technique. Laser Acupuncture The intensity of the stimulation from the Pilot HED (High Energy Density) optical fiber has been shown to have biological effects similar to those of metal needles and have a broad range of photobiostimulative effects. The cerebral and peripheral effects of laser needle acupuncture have been scientifically proven in studies and articles published in many peer-reviewed publications. Acupuncture treatments with lasers are completely painless, free from side effects, and very popular with all veterinary patients! Many clinicians and at least one research study comparing laser acupuncture and classic metal needles show that Laser Acupuncture produces superior results. With Laser Acupuncture, points are chosen in accordance with classical acupuncture protocols. Good therapeutic results are achieved in the treatment

of back pain, joint pain, soft tissue injuries, osteoporosis, respiratory and neurological disorders and many other conditions. Pain Therapy A particular approach in pain therapy is to employ low-dose Transcutaneous Optical Nerve Stimulation (TONS). The optical fiber tip is placed on the painful area and activated in a low-power level of around 1W. In addition producing analgesic effects thought to be similar to those of TENS (electrical nerve stimulation), laser irradiation induces an increase of cellular energy in the target tissue by increased ATP synthesis, greater oxygenation and enhanced capillary blood flow. Orthopedic and Physiotherapeutic Indications Orthopedic conditions that respond positively to Laser Acupuncture treatment include cervical syndromes, epicondylitis, fibromyalgia, osteoporosis, osteoarthritis, humerus scapularis, spinal syndromes, tendinitis, and more. PILOT LASER OPTICAL FIBER MANAGEMENT SYSTEM: The unique Pilot Laser Fiber Management System offers distinct advantages when treating a large number of patients. In a high-volume clinic, a therapy laser might be used for prolonged time periods (for example, 20 patients/day times 20 minutes per patient equals 400 minutes, or 6 hours and 45 minutes or more of use in one day). As a result of the high level of heat discharge at the fiber tip (approximately 300 C depending on maximum power setting), all diode lasers experience gradual decay of the fiber-optic cable tip over prolonged usage of several days to several months. Because of this, the CAO Group has developed a unique motorized fiber management system that allows the laser operator to refresh the cable tip through the simple method of stripping approximately of the protective cover from the 20 of 400 micron quartz/silica fiber provided, and cleaving the stripped portion of the silica fiber to create a fresh tip. This method of ensuring a fresh fiber tip is unique to the Pilot laser, and is not available from any other laser manufacturer. Recently the Pilot laser was taken to one of the busiest chiropractic clinics in the U.S., where more than 100 patients are treated daily. This clinic focuses on back decompression and deep-tissue laser therapy as primary treatment modalities, and utilizes ten decompression tables and eight 10W therapy lasers of another brand. A study was done utilizing the NOVA II laser-metering device by Ophir, where maximum power output and laser calibration were tested on all eight of the 10W lasers as well as the Pilot laser. The results were surprising, and showed that all but one of the 10W lasers were emitting maximum power output far below their designated range, and noticeably less than the 9W Pilot laser, primarily due to calibration and fiber decay issues common to all class IV diode lasers. Seven of the eight-10W lasers ranged in maximum power output from 5.8W to 8.3W, while the 9W Pilot laser power output was steady at 8.8 W. The clinic was not able to be without even one of their lasers for the three weeks it took to send the laser back to the factory to have the fiber-optic cable tip refreshed, nor were they happy about spending up to $1,500 every time a fiber tip needed servicing. The same process that required the clinic to be without one of their 10W lasers for up to three weeks and pay $1,500 every time a fiber-optic cable tip needed servicing, can be done in as little as 3-5 minutes at zero cost with the Pilot laser, saving the clinic thousands of dollars in servicing costs and lost revenue. Unlike other lasers, the Pilot laser provides constant maximum power output due to the patented Fiber Management System process, which allows a laser operator to refresh the fiber tip anytime a laser power output drop-off is suspected.