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Intended Use(s) of the Device:

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 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 ÝRemoval
  • Frenectomy
  • Frenotomy
  • Gingival Incision and Excision
  • Gingivectomy
  • Gingivoplasty
  • Laser curettage (removal of diseased or inflamed soft tissue in the periodontal pocket)
  • Operculectomy
  • Sulcular Debridement
  • Tissue retraction for Impression
  • Vestibuloplasty.
Additional indications cleared under 510(k) #014272:
  • 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, gingival bleeding index, probe depth, attachment level and tooth mobility