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510(k) Data Aggregation
K Number
K100474Device Name
QUICKLASEDUAL+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 MODEL: 3W,5W,3W,5W
Manufacturer
QUICKLASE LIMITED
Date Cleared
2010-03-16
(26 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
QUICKLASE LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For the incision, excision, ablation, vaporization, hemostasis, and treatment of oral soft tissue.
Examples:
Excisional and incisional biopsies
Exposure of unerupted teeth
Fibroma removal
Gingivoplasty
Hemostasis and coagulation
Incision and drainage of abscess
Operculectomy
Pulpotomy
Reduction of gingival hypertrophy
Soft Tissue crown lengthening
Vestibuloplasty
Laser Soft Tissue Curettage
Tissue Retraction
Frenectomy and Frenotomy
Gingival Troughing for crown impressions
Gingivectomy
Ginigival incision and excision
Implant Recovery
Leukoplakia
Oral papillectomies
Pulpotomy as an adjunct to root canal therapy
Reduction of bacterial level (decontamination) and inflammation
Treatment of aphthous ulcers
Lesion (tumor) removal
Treatment of canker sores, herpetic and other ulcers of the oral mucosa
Removal of Diseased, Inflamed and necrotic soft tissue within the periodontal pocket
Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithlium
Sulcular debridement (removal of necrotic, diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices ingluding gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility
Light activation of bleaching materials for teeth whitening
Laser-assisted whitening/bleaching of teeth
Device Description
The laser source of the QuickLase™DUALDental Lasers or QuickLase™810/980 Dental Laser is an array of Gallium Aluminum Arsenide (GaAlAs), solid state, semiconductor diode lasers. The individual lasers comprising the array are capable of producing invisible infrared laser energy at either 810 or 980 nanometers depending upon the concentration of and construction of the epitaxial layers of the diode. The delivery system consists of a fiber optic cable with a nominal diameter of 400 microns. In all available configurations, that portion of the delivery system that is handled by the operator and/or in contact with the patient can be sterilized by heat, steam, gas, chemicals or combinations thereof. Activation of the laser occurs after the operator either selects or enters the parameters for the procedure, verifies and authorizes the parameters and depresses a footswitch which fires the laser. The footswitch is an on/off switch. The interface for input is electro-mechanical by way of a membrane switch pad. The laser operates in continuous wave or pulse mode which is selected and/or verified by the operator. A visible aiming beam is provided in the form of a visible red laser which emits not more than 5mW (user adjustable and verified) in the 640-650 nanometer wavelength range.
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