(29 days)
Dental Soft Tissue Indications for: Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications: - Excisional and incisional biopsies - Exposure of unerupted teeth - A Fibroma removal - A Frenectomy - V Frenotomy - A Gingival troughing for crown impressions - ア Gingivectomy - ア Gingivoplasty - ﺗﯜ Gingival incision and excision - ﺮ Hemostasis and coagulation - ア Implant recovery - ア Incision and drainage of abscess - ア Leukoplakia - ﺮ Operculectomy - ア Oral papillectomies - > Pulpotomy - ア Pulpotomy as an adjunct to root canal therapy - ﻟﻠﺘﺮ Reduction of gingival hypertrophy - Soft tissue crown lengthening A - A Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa - A Vestibuloplasty Laser Periodontal procedures, including: - A Laser soft tissue curettage - A Laser removal of discased, inflamed and necrosed soft tissue within the periodontal pocket - A Sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)
The ezlase™ 10W dental diode laser system may be used to perform various dental soft tissue applications. The system uses advanced laser technology to incise, excise, vaporize, coagulate and ablate intraoral soft tissues. An Indium Gallium Arsenide Phosphorus solid-state laser diode emits infrared laser energy to the various oral soft tissues targeted during a procedure. This energy is transmitted via a flexible fiberoptic cable to the handpiece that emits the energy to the targeted tissue site. A visible light is emitted at the same time to visually pinpoint the treatment location. The power output and pulse width may be adjusted to specific user requirements.
This document does not describe an acceptance criteria or a study that proves the device meets specific acceptance criteria.
Instead, this document is a 510(k) summary statement for the Biolase ezlase™ 10W dental diode laser system. It focuses on demonstrating substantial equivalence to previously cleared predicate devices (ezlase™ K061898 and Twilight™ K991994) for its stated indications for use.
Here's why the requested information cannot be extracted from this document:
- No Acceptance Criteria or Performance Data: The document lists the device's indications for use and describes its technology but does not provide any quantitative metrics, thresholds, or performance targets that the device must meet (i.e., acceptance criteria). Consequently, there is no "reported device performance" to compare against such criteria.
- No Study Described: The document explicitly states, "There are no new indications requested for this device in this Special 510(k). Substantial equivalency for the ezlase™ 10W has been determined through comparison to previously cleared devices." This indicates that no new clinical study was conducted or is being presented as part of this submission to demonstrate the device's efficacy or safety. The approval is based on its similarity to existing, cleared devices.
Therefore, since no study is presented, the subsequent questions about sample size, data provenance, experts, adjudication, MRMC studies, standalone performance, ground truth, and training set information are not applicable to this document.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.