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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.

The provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) summary and FDA clearance letter for the PerioLase Dental Laser System. It focuses on demonstrating substantial equivalence to pre-existing legally marketed predicate devices, rather than presenting a study proving a device meets specific performance metrics.

Specifically, the "Clinical Performance Data" section explicitly states "N/A" (Not Applicable), and the "Summary Basis of Equivalence" states, "The PerioLase is essentially identical to the InPulse Laser System. The indications for use and intended uses are also identical. There are no new safety issues." This indicates that the clearance was based on similarity to already approved devices, not new clinical performance data or studies defining and meeting specific acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text.

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