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510(k) Data Aggregation
(219 days)
Intended Use / Indications for Use
(970nm and 445nm): Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter dental and epithelial lining of free gingiva and is indicated for: frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivectomy; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of diseased epithelial lining; incisions and draining of abscesses; tissue retraction for impressions; papillectomy; vestibuloplasty; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; 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 inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision and excision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy.
Whitening(970nm and 445nm): For light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth.
Low Level Laser Therapy(660nm and 970nm): To emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.
The 445nm, 970nm and 660nm laser radiation of the MateLaser is generated via different laser diodes inside the control unit and guided to the treatment region via quartz fibers. The laser radiation is absorbed by the tissue and converted to heat used for cutting, coagulation, germ reduction and desensitization, muscle relief. The device primarily consists of the main unit, a fiber optic handlpiece, a Type-C cable, and a power adapter.
The device operates in two distinct emission modes: CW (Continuous Wave) mode, which provides a continuous, uninterrupted laser beam and ISP (pulse) mode, which interrupts the laser beam at regular intervals with adjustable duty cycles. The MateLaser Medical Diode Laser Systems (Model ML-DLS-30) features a home screen interface that allows operators to configure treatment parameters including wavelength selection (445nm, 660nm, or 970nm), power settings, duty cycle, frequency, and treatment time. During operation, users navigate through the home screen to set parameters, switch from standby to ready mode, and initiate and initiate laser emission while monitoring battery status, total energy output, and treatment countdown. The device specifications include optical power ranges of 0.2-3W for 445nm and 970nm wavelengths and 25-100mW for 660nm.
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