(86 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, Fibroma removal, Frenectomy, Frenotomy, Gingival troughing for crown impressions, Gingivectomy, Gingivoplasty, Gingival incision and excision, Hemostasis and coagulation, Implant recovery, Incision and drainage of abscess, Leukoplakia, Operculectomy, Oral papillectomies, Pulpotomy, Pulpotomy as an adjunct to root canal therapy, Reduction of gingival hypertrophy, Soft tissue crown lengthening, Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa, Vestibuloplasty, Tissue retraction for impression. Laser Periodontal procedures, including: Laser soft tissue curettage, Laser removal of diseased, infected, inflamed and necrosed soft tissue within the periodontal pocket, Sulcular debridement (removal of diseased, infected, 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 iLase™ dental soft tissue laser is a surgical device designed for a wide variety of dental soft tissue procedures. It is capable of storing up to twelve soft tissue procedure settings. The iLase™ uses a solid state laser diode as a source of invisible infrared radiation. The energy is delivered to the treatment site via the ezTip® a single-use fiber optic tip assembly. Several types of ezTips® are available for use with the iLase™ to perform different procedures. The iLase™ is a Class II medical laser device and is sold only to licensed practitioners. The iLase™ system consists of two elements: I. The handpiece contains the laser diode, the replaceable fiber optic ezTip®, removable shroud, a microprocessor, control program, memory, integrated finger switch, organic LED (OLED) display, and rechargeable battery. The handpiece delivers laser energy, under user control, to the treatment site. II. The battery charger is used for charging and storing the handpiece. Discharged batteries are placed in receptacles in the charging station where they are automatically recharged. The charging station is furnished with a low voltage power supply.
The provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is a 510(k) summary statement for the iLase™ dental diode laser, focusing on demonstrating substantial equivalence to predicate devices rather than presenting performance study results against specific acceptance criteria.
The document includes:
- Device description
- Indications for use
- Contraindications
- A conclusion of substantial equivalence
- An official FDA letter confirming clearance
It explicitly states: "Substantial equivalency for the iLase™ has been determined through comparison to previously cleared dental diode lasers." This indicates that the regulatory clearance was based on similarity to existing devices, not on a new clinical performance study with defined acceptance criteria.
Therefore, I cannot provide the requested table or answer the questions related to sample size, ground truth, expert opinions, or MRMC studies, as this information is not present in the provided text.
§ 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.