PerioLase Nd:YAG Pulsed Dental Laser System

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, 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 and plastic surgery, neurosurgery, gynecology, urology, 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 inflamed soft tissue 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 new-attachment to the root surface in the absence of long junctional epithelium) • 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

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, 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 and plastic surgery, neurosurgery, gynecology, urology, ophthalmology, and pulmonary surgery. The following are the oropharyngeal indications for use for which the device will be marketed: 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 inflamed soft tissue 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 new-attachment to the root surface in the absence of long junctional epithelium), 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.

The PerioLase Nd:YAG Pulsed Dental Laser System 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, which 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 microprocessor-controlled switching circuit. The output energy of each laser pulse is measured by the internal energy monitor. 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 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 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. Wavelength: 1.064 microns (1064 nm), Pulse Energy: 20 to 300 mJ, Pulse Width: 100 µsec to 650 µsec, Repetition Rate: 10 to 100 Hz, Average Power: 6 Watts maximum, Laser Classification: Class IV.