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The PerioLase Nd: YAG Pulsed Dental Laser System is intended for use in laser surgery procedures for ablation, incision, excision, vaporization, and coagulation of soft tissues in specialties such as general and cosmetic dentistry, oral, maxillofacial, and cosmetic surgery, otolaryngology / ENT surgery, arthroscopy, dermatology and plastic surgery, gastroenterology, general surgery, gynecology, neurosurgery, ophthalmology, podiatry, pulmonary surgery, and urology. Orophayrngeal / Dental Surgery - Abscess incision and drainage - Aphthous ulcers treatment - Biopsies, incisional and excisional - Excision and ablation of benign lesions and conditions - Excision and vaporization of herpes simplex I and II - Exposure of unerupted / partially erupted teeth - Facilitation of subgingival calculus removal - Fibroma removal - Frenectomy - Frenotomy - Gingival incision and excision - Gingival troughing for crown impressions - Gingivectomy - Gingivoplasty - Hemostasis - Hemostatic assistance - Implant recovery - Incision of infection when used with antibiotic therapy - Laser-assisted new attachment procedure (cementum-mediated periodontal ligament no the root surface in the absence of long junctional epithelium) - Laser-assisted uvulopalatoplasty (LAUP) - Lesion (tumor) removal - Leukoplakia - Modification of the dentin surface, including increasing the mineral and decreasing the organic composition of the dentin surface, reducing bacteria on the dentin surface, improving the shear bond strength of composite resin, reducing the adhesive failure of composite resin, and removing demineralized dentin surfaces - Operculectomy - Oral papillectomy - Periodontal regeneration - true regeneration of the attachment apparatus (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface when used specifically in the LANAP® Protocol - Pulpotomy - Pulpotomy as an adjunct to root canal therapy - Reduction of denture hyperplasia - Reduction of gingival hypertrophy - Removal of filling material such as gutta percha or resin as an adjunct treatment during root canal retreatment - Removal of post-surgical granulations - Selective ablation of enamel (first degree) caries removal - Soft tissue crown lengthening - Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level or loss, and tooth mobility - Tissue retraction for impression - Vestibuloplasty General Surgery Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, and coagulation of soft tissue). All soft tissue is included, striated and smooth tissue, meniscus, mucous membrane, lymph vessels and nodes, organs and glands - Appendectomy - Cholecystecomy - Debridement of decubitus ulcers - Hemorrhoidectomy - Hepatectomy - Herniorrhaphy - Lymphadenectomy - Mastectomy - Pancreatectomy - Parathyroidectomy - Partial nephrectomy - Pelvic adhesiolysis - Pilonidal cystectomy - Removal of fibromas - Removal of lesions - Removal of polyps - Removal of tumors - Resection of lipoma - Splenectomy - Thyroidectomy - Tonsillectomy - Tumor biopsy Endonasal Surgery Endonasal surgery (ablation, vaporization, incision, and coagulation of soft tissue) including: - Adenoidectomy - Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal tissues - Tonsillectomy Dermatology and Plastic Surgery Dematology and plastic surgery (ablation, vaporization, excision, and coagulation of soft tissue) including: - Debridement of decubitus ulcer - Hemangiomas - Lesions of skin and subcutaneous tissue - Periungual and subungual warts - Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemangiomae, warts, telangiectasiae, rosacea, venous lake, leg veins, and spider veins - Plantar warts - Port wine lesions - Removal of tattoos - Spider veins - Telangiectasia - Treatment of keloids - Treatment of mild to moderate inflammatory acne vulgaris - Treatment of wrinkles - Venous lakes Podiatry (ablation, vaporization, excision, and coagulation of soft tissue) including: - Matrixectomy - Periungual and subungual warts - Plantar warts - Radical nail excision - Neuromas The PerioLase® MVP-7™ is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

The laser head consists of a flashlamp-pulsed Nd:YAG rod in an optical resonant cavity. The energy and the width of each laser pulse are determined by the size and shape of the current pulse through the flashlamp. The current pulse through the flashlamp is controlled by the flashlamp switching circuit. This circuit is based on a solid-state switch that sets the current level and pulse width according to the microprocessor controller. The rate at which the laser pulses are produced, the repetition rate or the pulses/second, is also determined by the microprocessorcontrolled switching circuit. The output energy of each laser pulse is measured by the internal energy monitor. This value is compared to the energy setting by the microcontroller and adjustments are made if necessary. The laser beam emitted from the laser head is coupled into a fiber-optic cable at the fiber port. The presence of the fiber-optic cable is detected by a sensor such that the laser will not fire if the fiber-optic cable is not in place. The laser aperture is at the distal tip of the fiber. The laser head is cooled by circulating water whose excess heat is removed by an air-water heat exchanger. The operator controls the laser through the touch screen display. The microcontroller handles all of the logic required to set the energy levels, pulse widths, and repetition rates for the laser output, monitors the output pulses to assure proper output energy, monitors all of the interlocks and sensors, and checks for proper operation of the switches, power supplies, and cooling system. Proper operation of the microcontroller is checked by an independent watchdog microprocessor. The system is designed such that no single fault can result in a system failure. All of the requirements of the laser safety standards of the CDRH as well as of the IEC 60825-1 standard are incorporated, including the remote interlock connector, the laser stop button, the key control, and the safety and manufacturer's labels.

The PerioLase Nd: YAG Pulsed Dental Laser System is to provide the ability to perform intraoral soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The PerioLase is intended for ablating, incising, vaporization and coagulation of soft tissues using a contact fiber-optic delivery system. The following areas: general and cosmetic dentistry, otolary, arthroscopy, gastroenterology, general surgery, dermatology and plastic surgery, neurosurgery, gynecology, ophthalmology, and pulmonary general surgery. The following are the oropharyngeal indications for use for which the device will be marketed: Oropharyngeal - · Abscess incision and drainage - · Aphthous ulcers treatment - · Biopsies excision and incision - · Crown lengthening - · Hemostatic assistance - Fibroma removal - · Frenectomy - · Frenotomy - Gingival incision and excision - · Gingivectomy - Gingivoplasty - · Operculectomy - · Oral papillectomy - · Tissue retraction for impression - · Vestibuloplasty - · Selective ablation of enamel (first degree) caries - · Exposure of unerupted / partially erupted teeth - · Implant recovery - · Lesion (tumor) removal - · Leukoplakia - · Pulpotomy - · Pulpotomy as adjunct to root canal therapy - · Removal of filling material such as gutta-percha or resin as adjunct treatment during root canal retreatment · Sulcular debridement (removal of diseased or in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level and tooth mobility · Laser-assisted new attachment procedure (cementum-mediated periodontal ligament to the root surface in the absence of long junctional epithelium) · Periodontal regeneration of the attachment apparatus (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface when used specifically in the LANAP® Protocol

The laser head consists of a flashlamp-pulsed Nd:YAG rod in an optical resonant cavity. The energy and the width of each laser pulse are determined by the size and shape of the current pulse through the flashlamp. The current pulse through the flashlamp is controlled by the flashlamp switching circuit. This circuit is based on a solid-state switch that sets the current level and pulse width according to the microprocessor controller. The rate at which the laser pulses are produced, the repetition rate or the pulses/second, is also determined by the microprocessorcontrolled switching circuit. The output energy of each laser pulse is measured by the internal energy monitor. This value is compared to the energy setting by the microcontroller and adjustments are made if necessary. The laser beam emitted from the laser head is coupled into a fiber-optic cable at the fiber port. The presence of the fiber-optic cable is detected by a sensor such that the laser will not fire if the fiber-optic cable is not in place. The laser aperture is at the distal tip of the fiber. The laser head is cooled by circulating water whose excess heat is removed by an air-water heat exchanger. The operator controls the laser through the touch screen display. The microcontroller handles all of the logic required to set the energy levels, pulse widths, and repetition rates for the laser output, monitors the output pulses to assure proper output energy, monitors all of the interlocks and sensors, and checks for proper operation of the switches, power supplies, and cooling system. Proper operation of the microcontroller is checked by an independent watchdog microprocessor. The system is designed such that no single fault can result in a system failure. All of the requirements of the laser safety standards of the CDRH as well as of the IEC 60825-1 standard are incorporated, including the remote interlock connector, the laser stop button, the key control, and the safety and manufacturers labels.

The following are the oral-pharngeal indications for use for which the device will be marketed: Abscess Incision and Drainage Apthous Ulcers Treatment Biopsies Excision and Incision Crown lengthening Hemostatic assistance Fibroma Removal Frenectomy Frenotomy Gingival Incision and Excision Gingivectomy Gingivoplasty Operculectomy Oral Papillectomy Tissue retraction for Impression Vestibuloplasty. Selective ablation of enamel (first degree) caries Exposure of unerupted / partially erupted teeth Implant recovery Lesion (tumor) removal Leukoplakia Pulpotomy Pulpotomy as adjunct to root canal therapy Removal of filling material such as gutta percha or resin as adjunct treatment during root canal re-treatment Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingivaltooth mobility tooth mobility. The PerioLase Nd: YAG Dental Laser System is to provide the ability to perform intraoral soft tissue dental, general, oral maxillo-facial and cosmetic surgery. The PerioLase is intended for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact fiber optic delivery system. The device will be used in the following areas: general and cosmetic dentistry otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery. The following is the additional oral-pharngeal indication for use for which the device will be marketed: Laser assisted new attachment procedure (cementum-mediated periodontal ligament new- attachment to the root surface in the absence of long junctional epithelium.)

The PerioLase is a FR Nd:YAG laser producing laser emission at 1064nm with variable pulse durations (100-650µsec). The laser consists of two interconnected sections: The cabinet which houses the laser head, the power supply, the cooling system and the microprocessor with control panel; and the fiber optic delivery system.

The PerioLase Nd: YAG Dental Laser System is to provide the ability to perform intraoral soft tissue dental. general, oral maxillo-facial and cosmetic surgery. The PerioLase is intended for ablating, incising. excising. vaporization and coagulation of soft tissues using a contact fiber optic delivery The Sevice will be used in the following areas: general and cosmetic dentistry sy stem. otolary ngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, neurosurgery, gynecology, urology, ophthalmology and pulmonary surgery. The following are the additional oral-pharngeal indications for use for which the device will be marketed: - . Selective ablation of enamel (first degree) caries - Exposure of unerupted / partially crupted teeth - Implant recovery ● - l.esion (tumor) removal . - Leukoplakia . - Pulpotomy - Pulpotomy as adjunct to root canal therapy - Romoval of filling material such as gutta percha or resin as adjunct treatment during root canal re-treatment - Sulcular debridement (removal of diseased or inflamed soft tissue in the periodonal pecket) to improve clinical indiccs including gingival bleeding index, probe depth, attachment level and tooth mobility The following are the oral-pharngeal indications for use for which the device will be marketed: Abscess Incision and Drainage Apthous Ulcers Treatment Biopsies Excision and Incision Crown lengthening Hemostatic assistance Fibroma Removal Frencctomy Frenotomy Gingival Incision and Excision Gingivectority Gingivoplasty Operculectomy Oral Papillectomy Tissue retraction for Impression Vestibuloplasty. Selective ablation of enamel (first degree) caries Exposure of unerupted / partially erupted teeth Implant recovery Lesion (tumor) removal Leukoplakia Pulpotomy Pulpotomy as adjunct to root canal therapy Removal of filling material such as gutta percha or resin as adjunct treatment during root canal retreatment Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level and tooth mobility

The PerioLase is an Nd:YAG laser producing laser emission at 1064nm. The laser consists of two interconnected sections: The cabinet which houses the laser head, the power supply, the cooling system and the microprocessor with control panel; and the fiber optic delivery system.