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    K Number
    K122368
    Device Name
    WATERLASE IPLUS ALL TISSUE LASER
    Manufacturer
    BIOLASE TECHNOLOGY, INC.
    Date Cleared
    2013-05-02

    (269 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOLASE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Orthopedic iPlus Soft Tissue Loser is intended for use as a laser surgical instrument in orthopedic and podiatric surgery. It is indicated for the following Indications for Use, including the previously cleared dental indications, for completeness: DENTAL INDICATIONS FOR USE General Indications* - Class I, II, III, IV and V cavity preparation - Caries removal - Hard tissue surface roughening or etching - Enameloplasty, excavation of pits and fissures for placement of sealants *For use on adult and pediatric patients Root Canal Hard Tissue Indications - Tooth preparation to obtain access to root canal - Root canal preparation including enlargement - Root canal debridement and cleaning Root Canal Disinfection - Laser root canal disinfection after endodontic treatment Endodontic Surgery (Root Amputation) Indications - Flap preparation incision of soft tissue to prepare a flap and expose the bone - Cutting bone to prepare a window access to the apex (apices) of the root(s) - Apicoectomy amputation of the root end - Root end preparation for retrofill amalgam or composite - Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. Bone Surgical Indications - Cutting, shaving, contouring and resection of oral osseous tissues (bone) - Osteotomy Soft Tissue Indications including Pulpal Tissues* Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including: - Excisional and incisional biopsies - Exposure of unerupted teeth - Fibroma removal - Flap preparation - incision of soft tissue to prepare a flap and expose the bone - Flap preparation - incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions) - Frenectomy and frenotomy - Gingival troughing for crown impressions - Gingivectomy - Gingivoplasty - Gingival incision and excision - Hemostasis - Implant recovery - Incision and drainage of abscesses - Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery - Leukoplakia - Operculectomy - Oral papillectomies - Pulpotomy - Pulp extirpation - Pulpotomy as an adjunct to root canal therapy - Root canal debridement and cleaning - Reduction of gingival hypertrophy - Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. - Soft tissue crown lengthening - Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa - Vestibuloplasty *For use on adult and pediatric patient Laser Periodontal Procedures - Full thickness flap - Partial thickness flap - Split thickness flap - Laser soft tissue curettage - Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket - Removal of highly inflamed edematous tissue affected by bacterial perpetration of the pocket lining junctional epithelium - Removal of granulation tissue from bony defects - Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss and tooth mobility) - Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours) - Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.) - Osseous crown lengthening - Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage - Waterlase MD Er,Cr:YSSG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium) ORTHOPEDIC INDICATIONS FOR USE Incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an arthroscope, in contact and non-contact with tissue, in orthopedic and podiatric surgery, including: - Soft and cartilaginous tissue in small and large joints (e.g., knee meniscectomy, debridement of inflamed synovial tissue)
    Device Description
    The Orthopedic iPlus Soft Tissue Laser is an erbium, yttrium, scandium, gallium garnet (Er, Cr:YSGG) solid state laser that provides optical energy to the user controlled distribution of atomized water droplets at 2.78 μm (2780 nm). The laser consists of a cabinet which houses the power supply, the cooling system, microcontroller, laser, foot switch, and fiber optic for delivery of laser energy with fiber optic handpiece setup. The Orthopedic iPlus Soft Tissue Loser utilizes direct laser energy either with or without water for cooling and hydration to perform soft tissue incision, resection, ablation, vaporization, coagulation and hemostasis.
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    K Number
    K130465
    Device Name
    EPIC 10S
    Manufacturer
    BIOLASE TECHNOLOGY, INC.
    Date Cleared
    2013-04-11

    (45 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOLASE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Epic 10S is intended for use as a laser surgical instrument in general and plastic surgery and in dermatology. It is indicated for the following expanded Indications for Use: Ear, Nose and Throat and Oral Surgery, Arthroscopy, Gastroenterology, Orthopedics, General Surgery, Dermatology & Plastic Surgery, and Podiatry, GI/GU, Gynecology, Neurosurgery, Ophthalmology, Pulmonary Surgery, Cardiac Surgery, Thoracic Surgery, Urology, Dermatology/Aesthetics, Vascular Surgery.
    Device Description
    The EPIC 10S system uses an Indium Arsenide Phosphorous (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a handpiece that emits the energy to the target site. A visible light is emitted at the same time to visually identify the treatment location. The EPIC 10S laser is comprised of a base console, a detachable delivery system, tips, and a wireless footswitch. Various types of the single use tips are included for different applications and the device is activated by means of a wireless footswitch. The Epic 10S delivery system consists of the following: Fiber Optic Assembly, Surgical Handpiece, and Single-use tips.
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    K Number
    K121327
    Device Name
    DIOLASE 10S
    Manufacturer
    BIOLASE TECHNOLOGY, INC.
    Date Cleared
    2013-02-01

    (275 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOLASE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ear, Nose and Throat and Oral Surgery: Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity. Arthroscopy: Hemostasis, incision, excision, coagulation, vaporization, and ablation of joint tissues during arthroscopic surgery. Gastroenterology: Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy. Orthopedics: Dissect and coagulate. General Surgery, Dematology & Plastic Surgery, and Podiatry: Excision, ablation, vaporization, and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation, and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue, and dermabrasion. GI/GU: Excision, vaporization, and hemostasis of abdominal and rectal tissues. Gynecology: Ablation, excision, incision, coagulation, hemostasis, and vaporization of tissue. Neurosurgery: Vaporization, coagulation, excision, incision, ablation and hemostasis of tissue. Ophthalmology: Dacryocystorhinostomy transcanalicular, Open DCR, Tumor Excision, Blepharoplasty. Pulmonary Surgery: Hemostasis, vaporization, coagulation, incision, ablation, and excision of tissue. Cardiac Surgery: Coagulation and hemostasis of cardiac tissue. Thoracic Surgery: Thoracotomy, Pulmonary resection, Hemostasis, Pericardiectomy, Adhesiolysis, Coagulation of blebs and bullae. Urology: Hemostasis, vaporization, incision, coagulation, ablation, and excision of tissues. Dermatology/Aesthetics: Photocoagulation of vascular & dermatological lesions of the face and extremities, Photocoagulation of telangiectasia, venulectasia of the legs and face, Treatment of reticular veins and branch varicosities, Pyrogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas, Superficial benign vascular lesions including Telangiectasias, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines. Epidermal nevi, spider nevi, Dermatological surgery: Condyloma acuminate, warts, small non-malignant skin tumors, small semi-malignant tumors as basaliomas, Bowe, Kaposi sarcoma. Warty leucoplasty and ulcers debridement, Seborrheic keratosis, Mixoid cyst, Papillary varix, Acne treatment. Vascular Surgery: Photocoagulation of vascular & dermatological lesions of the face and extremities, Photocoagulation of telangiectasia, venulectasia of the legs and face, Treatment of reticular veins and branch varicosities.
    Device Description
    The Diolase™ 10S system uses an Indium Gallium Arsenide Phosphorous (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a hand piece that emits the energy to the target site. A visible light is emitted at the same time to visually identify the treatment location. The Diolase™ 10S laser consists of two permanently connected components: Console, and Delivery System. The Console has a Control Panel (Touch Screen and Keypad) in front and a detachable base attached at the bottom rear of the Console. The Diolase™10S Laser Delivery System consists of the following: Fiber Optic Assembly and Surgical Handpiece.
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    K Number
    K121286
    Device Name
    EPIC 10
    Manufacturer
    BIOLASE TECHNOLOGY, INC.
    Date Cleared
    2012-09-28

    (151 days)

    Product Code
    GEX, ILY
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOLASE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. 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 - 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 2. Laser Periodontal Procedures - Laser soft tissue curettage - Laser removal of diseased, 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.) 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 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.
    Device Description
    The EPIC™ 10 system uses an Indium Gallium Arsenide Phosphorous (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a hand piece that emits the energy to the target site. A visible light is emitted at the same time to visually identify the treatment location. The EPIC"" 10 Laser System is comprised of a Base Console, a detachable delivery system, tips, and a wireless footswitch. Various types of the single use tips are included for different applications and the device is activated by means of a wireless footswitch. The EPIC"" 10 Laser is a surgical and therapeutic device designed for a wide variety of oral soft tissue procedures and dental whitening, as well as for use in providing temporary relief of minor pain.
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    K Number
    K101658
    Device Name
    WATERLASE MD TURBO PLUS MODEL 7200XXX
    Manufacturer
    BIOLASE TECHNOLOGY, INC.
    Date Cleared
    2010-08-11

    (61 days)

    Product Code
    GEX, MXF
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOLASE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    General Indications: - Class I, II, III, IV and V cavity preparation - Caries removal - Hard tissue surface roughening or etching - Enameloplasty, excavation of pits and fissures for placement of sealants - * For use on adult and pediatric patients Root Canal Hard Tissue Indications: - Tooth preparation to obtain access to root canal - Root canal preparation including enlargement - Root canal debridement and cleaning Root Canal Disinfection: - Laser root canal disinfection after endodontic treatment Endodontic Surgery (Root Amputation) Indications: - Flap preparation incision of soft tissue to prepare a flap and expose the bone. - Cutting bone to prepare a window access to the apex (apices) of the root(s). - Apicoectomy - amputation of the root end. - Root end preparation for retrofill amalgam or composite. - Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. Bone Surgical Indications: - Cutting, shaving, contouring and resection of oral osseous tissues (bone) - Osteotomy Soft Tissue Indications including Pulpal Tissues*: Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including: - Excisional and incisional biopsies - Exposure of unerupted teeth - Fibroma removal - Flap preparation incision of soft tissue to prepare a flap and expose the bone. - Flap preparation incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions) - Frenectomy and frenotomy - Gingival troughing for crown impressions - Gingivectomy - Gingivoplasty - Gingival incision and excision - Hemostasis - Implant recovery - Incision and drainage of abscesses - Laser soft tissue curettage of the post-extraction tooth sockets and the periapical area during apical surgery - Leukoplakia - Operculectomy - Oral papillectomies - Operculectomy - Oral papillectomies - Pulpotomy - Pulp extirpation - Pulpotomy as an adjunct to root canal therapy - Root canal debridement and cleaning - Reduction of gingival hypertrophy - Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic tissues (i.e., granulation tissue) from around the apex NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. - Soft tissue crown lengthening - Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa - Vestibuloplasty * For use on adult and pediatric patient Laser Periodontal Procedures: - Full thickness flap - Partial thickness flap - Split thickness flap - Laser soft tissue curettage - Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket - Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining junctional epithelium - Removal of granulation tissue from bony defects - Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) - Osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours) - Ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.) - Osseous crown lengthening - Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage - Waterlase MD Er,Cr:YSGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium)
    Device Description
    The Waterlase MD Turbo Plus is a dental laser device indicated for incision, excision, removal, and specific dental therapies, such as root canal therapy and periodontal therapy. All indications for use submitted for the Waterlase® MD Turbo Plus have been previously cleared by the FDA and there are no new indications included for this device.
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    K Number
    K093852
    Device Name
    EZLASE 3 LASER SYSTEM
    Manufacturer
    BIOLASE TECHNOLOGY, INC.
    Date Cleared
    2010-03-12

    (86 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOLASE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.)
    Device Description
    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.
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    K Number
    K091746
    Device Name
    WATERLASE MD, MODEL 7100102
    Manufacturer
    BIOLASE TECHNOLOGY, INC.
    Date Cleared
    2009-12-07

    (174 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOLASE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Removal of subgingival calculi in periodontal pockets with periodontitis by closed or open curettage.
    Device Description
    The Waterlase MD dental laser system is a device used to perform a variety of dental soft and hard tissue indications. For hard tissue procedures the Waterlase MD uses the Erbium,Chromium:Yttrium,Scandium,Gallium Garnet (Er,Cr.YSGG) laser in combination with advanced water atomization spray technology to cut, remove, shave, contour, roughen and etch tissues. Soft tissue procedures are performed using two different modes of operation. H and S. where direct Er.Cr. YSGG laser energy is applied to incise, excise or ablate these tissues. For soft tissue procedures the water spray is applied for hydration. cooling or to keep tissues and the field of view clean. For hard tissue applications the spray is part of the tissue removing process as well as hydration, cooling and keeping tissues and field of view clean. A flexible fiber optic terminated into the handpiece delivers the Waterlase®MD laser energy to the end fiber tip and target. A visible aiming light emitted from the handpiece's distal end pinpoints the area of treatment. Three fiber optic ports provide illumination from the handpiece to the tissue site in addition to the center beam emitting source. In both hard and soft tissue applications the power output, pulse duration, repetition rate (frequency) and air and water flow rates are adjustable to specific user requirements. The spot size and spot geometry can also be varied by changing tips which include different diameters and end configurations.
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    K Number
    K083927
    Device Name
    WATERLASE MD
    Manufacturer
    BIOLASE TECHNOLOGY, INC.
    Date Cleared
    2009-10-01

    (274 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOLASE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Waterlase MD Er,Cr:YSGG assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium).
    Device Description
    The Waterlase MD is a dental laser device previously cleared by the FDA (K031140) for hard and soft tissue dental indications, including periodontal procedures such as: laser soft tissue curettage, laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket, removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium, removal of granulation tissue from bony defects, sulcular debridement (removal of diseased, infected, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility), osteoplasty and osseous recontouring (removal of bone to correct osseous defects and create physiologic osseous contours), ostectomy (resection of bone to restore bony architecture, resection of bone for grafting, etc.), osseous crown lengthening, full thickness flap, partial thickness flap, and split thickness flap. The Waterlase MD is capable of soft tissue incision, excision, vaporization, ablation and coagulation. In the periodontal pocket, the Waterlase MD is an effective laser for removing diseased/inflamed tissue, and the diseased epithelium lining from underlying connective tissues. A flexible fiber optic terminated into the handpiece delivers the Waterlase MD laser energy to the end fiber tip and target. A visible aiming light emitted from the handpiece's distal end pinpoints the area of treatment. Three fiber optic ports provide illumination from the handpiece to the tissue site in addition to the center beam emitting source. In both hard and soft tissue applications the power output, pulse duration, repetition rate (frequency) and air and water flow rates are adjustable to specific user requirements. The spot size and spot geometry can also be varied by changing tips which include different diameters and end configurations.
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    K Number
    K091922
    Device Name
    WATERLASE C100, MODEL 7100104
    Manufacturer
    BIOLASE TECHNOLOGY, INC.
    Date Cleared
    2009-07-14

    (14 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOLASE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device may be used for the following indications (previously cleared under submissions K030523, K071363, and K081589): General Indications * - r Class I, II, III, IV and V cavity preparation - Caries removal - Hard tissue surface roughening or etching - Enameloplasty, excavation of pits and fissures for placement of sealants - * For use on adult and pediatric patients Root Canal Hard Tissue Indications - 이 Tooth preparation to obtain access to root canal - Root canal preparation including enlargement 트 - l Root canal debridement and cleaning Root Canal Disinfection - 트 Laser root canal disinfection after endodontic instrumentation Endodontic Surgery (Root Amputation) Indications - Flap preparation incision of soft tissue to prepare a flap and expose the bone. 트 - Cutting bone to prepare a window access to the apex (apices) of the root(s). l - Apicoectomy amputation of the root end. 트 - Root end preparation for retrofill amalgam or composite. 트 - Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic 트 tissues (i.e., granulation tissue) from around the apex NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. Bone Surgical Indications - Cutting, shaving, contouring and resection of oral osseous tissues (bone) ■ - . Osteotomy Soft Tissue Indications including Pulpal Tissues* Incision, excision, vaporization, ablation and coagulation of oral soft tissues, including: - 트 Excisional and incisional biopsies - I Exposure of unerupted teeth - I Fibroma removal - Flap preparation incision of soft tissue to prepare a flap and expose the bone. ■ - Flap preparation incision of soft tissue to prepare a flap and expose unerupted teeth . (hard and soft tissue impactions) - I Frenectomy and frenotomy - Gingival troughing for crown impressions I - 미 Gingivectomy - I Gingivoplasty - I Gingival incision and excision - 트 Hemostasis - I Implant recovery - .. Incision and drainage of abscesses - Laser soft tissue curettage of the post-extraction tooth sockets and the periapical 프 area during apical surgery - 트 Leukoplakia - Operculectomy 바 - 트 Oral papillectomies - l Operculectomy - Oral papillectomies 트 - 트 Pulpotomy - Pulp extirpation ■ - 트 Pulpotomy as an adjunct to root canal therapy - Root canal debridement and cleaning 트 - 트 Reduction of gingival hypertrophy - Removal of pathological tissues (i.e., cysts, neoplasm or abscess) and hyperplastic 트 tissues (i.e., granulation tissue) from around the apex NOTE: Any tissue growth (i.e., cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation. - Soft tissue crown lengthening ■ - Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa B - 트 Vestibuloplasty - * For use on adult and pediatric patient Laser Periodontal Procedures - s Full thickness flap - l Partial thickness flap - 트 Split thickness flap - 트 Laser soft tissue curettage - 트 Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket - Removal of highly inflamed edematous tissue affected by bacteria penetration of ■ the pocket lining junctional epithelium - Removal of granulation tissue from bony defects ■ - Sulcular debridement (removal of diseased, inflamed or necrosed soft I tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) - Osteoplasty and osseous recontouring (removal of bone to correct osseous defects . and create physiologic osseous contours) - Ostectomy (resection of bone to restore bony architecture, resection of bone for 프 grafting, etc.) - . Osseous crown lengthening
    Device Description
    The Waterlase C100 dental laser system is a diverse device utilized to perform a variety of dental applications. For hard tissue procedures the Waterlase® C100 uses the Erbium, Chromium, Yttrium, Scandium, Gallium Gamet (Er,Cr.YSGG) laser in combination with advanced water atomization spray technology to cut, remove, roughen and etch tissues. Soft tissue procedures are performed using a different mode of operation where direct Er, Cr.YSGG laser energy is applied to incise, excise or ablate these tissues. In soft tissue procedures the water spray is applied for hydration, cooling or to keep tissues clean. For hard tissue applications the spray is part of the tissue removing process as well as hydration, cooling and keeping tissues clean. A flexible fiberoptic handpiece delivers the Waterlase® C100 laser energy. A visible light emitted from the handpiece distal end pinpoints the area of treatment. In both hard and soft tissue applications the power output, pulse energy, repetition rate (frequency) and air and water flow rates are adjustable to specific user requirements.
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    K Number
    K083595
    Device Name
    EZLASE
    Manufacturer
    BIOLASE TECHNOLOGY, INC.
    Date Cleared
    2009-04-14

    (130 days)

    Product Code
    ILY, PRE
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOLASE TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ezlase™ diode system emits energy in the near- infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a 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.
    Device Description
    The ezlase™ diode laser system, was cleared for dental soft tissue indications under KQ61898 and K083069. The system uses a Gallium Aluminum Arsenide (GaAlA) and/or an Indium Gallium Arsenide Phosphorus (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiberoptic cable to a handpiece that emits the energy to the targeted site. A visible light is emitted at the same time to visually identify the treatment location.
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