Indications cleared under K010771

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.Ý The PerioLase is intended for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact fiber optic delivery system.Ý 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.Ý 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