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. 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 Removal

· 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