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510(k) Data Aggregation

    K Number
    K243764
    Device Name
    Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)
    Manufacturer
    Wuhan Pioon Technology Co., Ltd.
    Date Cleared
    2025-05-08

    (153 days)

    Product Code
    NVK, EEG, GEX, ILY
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    NVK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The UTU series Medical Diode Laser are intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and interdental and epithelial lining of free gingiva and are 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:** The UTU series Medical Diode Laser are indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth. **Low Level Laser Therapy:** The UTU series Medical Diode Laser are intended 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.
    Device Description
    The UTU series Medical Diode Laser (UTU3-F7B, UTU3-F7W, UTU3-G7B, UTU3-G7W, UTU-G20B and UTU-G20W) is a surgical and therapeutic device designated for a wide variety of oral soft tissue procedures and dental whitening as well as for use in providing a temporary relief of minor pain. The device utilizes a solid state diode as laser energy source. The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The device is activated by means of a footswitch. It is a portable medical device composed of a main unit, a laser delivery system, a footswitch, a power adapter and protective goggles. The main unit incorporates an LCD touchscreen for the device user to set output parameters and for control of the device, and a built-in large-capacity rechargeable lithium battery with longer time of endurance. The laser delivery system includes a fiber optic cable, handpiece and tips (disposable fiber tips, whitening tip, biostimulation tip or therapy tip) designed and optimized for different applications. The UTU3-F7B and UTU3-F7W employ the diodes with wavelengths of 810nm, 650nm and 450nm, they only different in enclosure color, the enclosure color of UTU3-F7B is black and the enclosure color of UTU3-F7W is white. The UTU3-G7B and UTU3-G7W employ the diodes with wavelengths of 980nm, 650nm and 450nm, they only different in enclosure color, the enclosure color of UTU3-G7B is black and the enclosure color of UTU3-G7W is white. The UTU-G20B and UTU-G20W employ the diode with wavelength of 980nm, they only different in enclosure color, the enclosure color of UTU-G20B is black and the enclosure color of UTU-G20W is white. The device emits laser output energy in the infrared, red and blue spectra respectively.
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    K Number
    K230047
    Device Name
    Medical Diode Laser Systems
    Manufacturer
    Gigaalaser Company Ltd.
    Date Cleared
    2024-03-04

    (423 days)

    Product Code
    NVK, EEG, GEX, ILY
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    NVK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medical Diode Laser Systems are intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivoplasty; 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;papillectorny; vestibuloplasty ; excision of lesions; exposure of unerupted partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket; sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including 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: Medical Diode Laser Systems are indicated for light activation materials for teeth whitening and for laser-assisted whitening/bleaching of teeth. Low Level Laser Therapy: Medical Diode Laser Systems are intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffins pain, or muscle spasm, and for the temporary increase in local blood circulation and/or temporary relaxation of muscles.
    Device Description
    The Medical Diode Laser System is a compact, air-cooled unit. It is a complete self-contained instrument, which includes a high efficiency power supply, a microprocessor controlled, adjustable light output with automatic power stabilization, (fan cooled), as well as a switch panel and LCD screen display panel designed to be user friendly. The system includes high power lasers, safety features and an SMA fiber output connector. The system includes a Lithium battery, it can work 1hour when not external power input at maximum power output in pulse or CW but intermittent mode. The diodes are made from GaAlAs semiconductor material for high output and superior reliability. The diode lasers are enclosed in a rugged, factory-aligned, replaceable, environmentally protective module. High-capacity fans eliminate the need for water-cooling, and assure low maintenance and reliable laser operation. The diodes convert electric energy into coherent laser radiation with a wavelength of 810nm or 980nm+/-10nm (pilot beam: 650nm+/-10nm).
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    K Number
    K232885
    Device Name
    Dawn Diode Laser System
    Manufacturer
    Shanghai Wonderful Opto-Electrics Tech Co., Ltd.
    Date Cleared
    2024-02-28

    (163 days)

    Product Code
    NVK, EEG, GEX, ILY
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    NVK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    450 nm, 635 nm and 980 nm Diode Laser: · Intended for intra- and extra-oral surgery including incision, hemostasis, coagulation and vaporization of soft tissue including marginal and inter-dental and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; biopsy; operculectomy; implant recovery; gingivoplasty; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tıssue; 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, inflamed and necrosed soft tissue within the periodontal pocket; sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth inability); pulpotomy; pulpotomy as adjunct to root canal therapy; fibroma removal; gingival incision; treatment of canker sores; herpetic ulcers of the oral mucosa; laser soft tissue curettage; reduction of gingival hypertrophy. Whitening: • Indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth. Low Level Laser Therapy: · Intended 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. 810 nm Diode Laser in dentistry: · Surgical applications requiring the ablation, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, otolaryngology, ophthalmology, and pulmonology · Oral/Maxillofacial Indications; Incision, excision, vaporization, ablation and/or coagulation of soft tissue - · Gingival troughing for crown impression - · Gingivectomy - · Gingivoplasty - · Gingival incision and excision - · Hemostasis and coagulation - · Excisional and incisional biopsies - · Fibroma removal - · Frenectomy and frenotomy - · Oral papillectomies - · Soft tissue crown lengthening - · Treatment of aphthous ulcers - · Treatment of herpetic lesions - · Periodontology; - · Laser soft tissue curettage - · Laser soft tissue curettage - · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket - · Cosmetic Dentistry; - · Laser-assisted bleaching/whitening of the teeth - · Light activation for bleaching materials for teeth whitening - · Implant recovery 810 nm Diode Laser in therapy: · Temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle. 1064 nm Diode Laser in dentistry: - · Excisional and incisional biopsies; - · Excision and vaporization of herpes simplex I and II; - · Frenectomy and frenotomy; - · Gingivectomy; - · Gingivoplasty; - · Gingival incision and excision; - · Hemostasis; - · Implant recovery; - · Operculectomy; - · Pulpotomy and pulpotomy as an adjunct to root canal therapy; - · Removal of filling material such as gutta percha or resin as adjunct treatment during root canal therapy; · Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility): · Treatment of aphthous ulcers and herpetic lesions
    Device Description
    The Dawn Diode Laser System manufactured by SWOT LASERS is a surgical device at the cutting edge of technology, designed for a wide variety of soft tissue procedures. The Dawn Diode Laser System utilizes a solid state diode as laser energy source. The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The device is activated by means of footswitch. This laser instrument consists of fiber connecting diode laser system, power supply system and microcomputer control system. The Dawn Diode Laser System employs the diodes with wavelengths of 450nm, 635nm, 810nm, 980nm and 1064nm, and the device emits laser output energy in blue (450nm), red (635nm), orange (980nm) spectra respectively.
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    K Number
    K232222
    Device Name
    Primo Dental Laser
    Manufacturer
    Medency S.r.l.
    Date Cleared
    2023-11-27

    (124 days)

    Product Code
    NVK
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    NVK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Dental Soft Tissue Indications incision, excision, vaporization and coagulation of oral soft-tissues including marginal and interdental gingival and epithelial lining of free gingiva and the following specific indications: - Excisional and incisional biopsies - Exposure of unerupted teeth - Fibroma removal - Frenectomy - Frenotomv - 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 adjunction 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 - Reduction of bacterial level (decontamination) and inflammation 2. Laser Periodontal Procedures - Laser soft-tissue curettage - Laser removal of diseased, inflamed and necrosed soft-tissue within periodontal pocket - Sulcular debridement (removal of diseased, inflamed and necrosed soft-tissue within periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility). 3. Whitening - Light activation for bleaching materials for teeth whitening - Laser-assisted whitening/bleaching of teeth 4. Pain Therapy - Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
    Device Description
    Primo Dental Laser is a laser medical device with surgical and therapeutic effects mainly used in dental and oral care. It's a portable medical device composed by a console, the principal component of the device, connected to a handpiece through an optical fiber, which represent the applied parts. Primo Dental Laser is a medical device used for a great variety of dental treatment including Surgery, Decontamination, Biostimulation and Therapy. All this due to the selection of protocols favourable through a wide spectrum of specialties. Laser radiation is produced by a laser diode. This component, a semiconductor, is able to produce a laser radiation with a wavelength characteristic of the semiconductor itself. Primo Dental Laser has the following characteristics: is transportable and equipped with an internal battery to be independent from the power supply. Laser emission occurs with a wireless pedal control, also powered by batteries. The radiation emitted by the diode laser is delivered to the optical fiber or through the use of an accessory.
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    K Number
    K221761
    Device Name
    Solea
    Manufacturer
    Convergent Dental, Inc.
    Date Cleared
    2022-09-14

    (89 days)

    Product Code
    NVK, GEX
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    NVK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Solea system is indicated for the following: - Ablation of hard tissue for caries removal and cavity prevention - Incision, excision, vaporization, coagulation and hemostasis of soft tissue in the oral cavity - Cutting, shaving, contouring and resection of oral osseous tissue (both) - Aiding in the reduction of mineral loss in dental enamel
    Device Description
    The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy for ablation of hard tissue for caries removal and cavity preparation; incision, excision, vaporization, coagulation, and hemostasis of soft tissue in the oral cavity; cutting, shaving, contouring and resection of oral osseous tissue (bone). The Solea system utilizes CO2 laser technology with a wavelength of 9.3 um. The modification to the cleared Solea system is the introduction of the DR Handpiece which allows the system to deliver controlled sub-ablative energy necessary to heat the tooth surface mineral without ablation for the new treatment of aiding in the reduction of mineral loss in the tooth enamel.
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    K Number
    K211150
    Device Name
    Dental diode laser, SOGA Laser, ILaser II
    Manufacturer
    Shenzhen Soga Technology Co., Ltd.
    Date Cleared
    2022-07-01

    (438 days)

    Product Code
    NVK, GEX
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    NVK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental Soft Tissue Indications: 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, Leukoplakcia, 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).
    Device Description
    Principle: The semiconductor laser diode is excited by the generation power supply to generate the laser, which is effectively transmitted to the treatment site through the optical fiber tip. Intended operator: Dental surgeon. Component part: It is composed of laser host (including internal power system, laser drive system, optical path system, LCD screen, emergency stop button, laser) and optic fiber tip. Sterile: The Fiber optic tip and the handpiece cover require sterilization prior to use.
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    K Number
    K214008
    Device Name
    Dental diode laser
    Manufacturer
    Shenzhen Soga Technology Co., Ltd.
    Date Cleared
    2022-05-10

    (139 days)

    Product Code
    NVK, GEX, PRI
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    NVK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue; marginal and interdental gingival and epithelial lining of free gingiva; frenotomy; biopsy; operculectomy; Implant recovery; gingivectomy; gingival troughing; crown lengthening; hemostasis of donor site; removal of granulation tissue; laser assisted flap surgery; debridement of deseased 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, inflamed and necrosed soft tissue within the periodontal pocket; 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 inability); pulpotomy; pulpotomy as adjunct to root canal therapy; Fibroma removal; Gingival incision; Treatment of canker sores; herpetic ulcers of the oral mucosa: Laser soft tissue curettage: Reduction of gingival hypertrophy:.
    Device Description
    The semiconductor laser diode is excited by the generation power supply to generate the laser, which is effectively transmitted to the treatment site through the optical fiber tip. It is composed of laser host (including internal power system, laser drive system, optical path system, LCD screen, emergency stop button, laser) and optic fiber tip. The device mainframe not supplied sterile and do not require sterilization prior to use. The consumable component (Fiber optic tip) not supplied sterile but require sterilization prior to use.
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    K Number
    K213658
    Device Name
    DEKA SMARTPERIO
    Manufacturer
    El.En Electronic Engineering Spa
    Date Cleared
    2022-03-11

    (112 days)

    Product Code
    NVK, GEX
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    NVK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DEKA SmartPerio system is intended to perform intraoral soft tissue dental, general, oral maxillofacial, and cosmetic surgery. The DEKA SmartPerio is intended for ablating, incising, excising, vaporization and coagulation of soft tissues using a contact fiber-optic delivery system. The device is intended to be used in dentistry. The following are the oropharyngeal indications for use: Abscess Incision and Drainage Apthous Ulcers Treatment Biopsies Excision and Incision Crown lengthening Hemostatic assistance Fibroma Removal Frenectomy Frenotomy Gingival Incision and Excision Gingivectomy 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. Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium.)
    Device Description
    The DEKA SmartPerio is a Nd:YAG laser device for soft-tissues intraoral treatments. The DEKA SmartPerio system delivers laser through an optical fiber that is guided to the target tissue with the aid of an handpiece and a tip. The modification to the device consists in the increasing of the average output power from 6W to 10W.
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    K Number
    K210367
    Device Name
    D-Laser Blue, D-Laser 16
    Manufacturer
    Guilin Woodpecker Medical Instrument Co., Ltd.
    Date Cleared
    2022-03-10

    (395 days)

    Product Code
    NVK, GEX, ILY
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    NVK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    D-Laser Blue and D-Laser 16 are intended for intra- and extra-oral surgery including incision, excision, hemostasis, coagulation and vaporization of soft tissue including marginal and epithelial lining of free gingiva and are indicated for: frenectomy; frenotomy; implant recovery; gingivectomy; 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: papillectory; vestibuloplasty ; excision of lesions; exposure of unerupted/partially erupted teeth; removal of hyperplastic tissues; treatment of aphthous ulcers; leukoplakia; laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket, sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including 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: D-Laser Blue and D-Laser 16 are indicated for light activation for bleaching materials for teeth whitening and for laser-assisted whitening/bleaching of teeth. Low Level Laser Therapy: D-Laser Blue and D-Laser 16 are intended to emit energy in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperary 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.
    Device Description
    The dental diode laser systems, D-Laser Blue and D-Laser 16, realize oral soft tissue surgery, periodontal disease, endodontic disease, pain treatment, soft laser therapy and other oral diseases by vaporizing, carbonizing and solidifying the tissue by laser. The device features include: Using a capacitive touch screen which has the clear display and is easy to operate; Builtin large-capacity rechargeable lithium battery with longer time of endurance; The handpiece sleeve and the fiber tip can be autoclaved to prevent from cross infection; Preset more than 20 treatment procedures to reduce the difficulty of use; A secure protection mechanism that automatically shuts down the device after 5 minutes of inactivity. The D-Laser Blue and the D-Laser 16 respectively consist of a main unit, a laser transmission system and a power adapter. The main unit includes a semiconductor laser, a power supply system and a control device, a safety protection device and a display device. The D-Laser Blue employs the diodes with wavelengths of 976nm, 650nm and 450nm, and the device emits laser output energy in the infrared, red and blue spectra respectively. The D-Laser 16 employs the diodes with wavelengths of 976nm and 650nm, and the device emits laser output energy in the infrared, red spectra respectively.
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    K Number
    K213428
    Device Name
    EdgePro
    Manufacturer
    Biolase Inc.
    Date Cleared
    2021-12-22

    (62 days)

    Product Code
    NVK, GEX
    Regulation Number
    878.4810
    Why did this record match?
    Product Code :

    NVK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Root Canal Hard Tissue Indications (for use on adult and pediatric patients) - Root canal preparation including enlargement - Root canal debridement and cleaning Root Canal Disinfection (for use on adult and pediatric patients) - Laser root canal disinfection after endodontic treatment
    Device Description
    EdgePro is an erbium, chromium: yttrium, scandium, gallium garnet (Er,Cr: YSGG)solid-state laser that provides optical energy to the user-controlled distribution of atomized water droplets at 2780 nm. The laser system consists of a top-table console which houses the laser head, power supply, cooling system, micro-processor and a removable tablet PC as a control panel. A flexible fiber cable, connected to the laser console, delivers laser energy to the treatment site through a laser tip attached to a Handpiece. A visible light emitted from the Handpiece head illuminates the area. The laser is activated by means of a wireless footswitch. Various laser tips are available for different clinical applications. EdgePro utilizes advanced laser and water atomization technologies to cut, shave, contour, roughen, etch and resect oral hard tissues, and direct laser energy, with or without water for cooling and hydration, to perform oral soft tissue removal, incision, excision, ablation and coagulation as well as specific endodontic and periodontal applications.
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