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510(k) Data Aggregation

    K Number
    K162114
    Device Name
    Photon, Photon Plus
    Manufacturer
    Zolar Technology & MFG Co. Inc.
    Date Cleared
    2016-12-12

    (136 days)

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

    **Zolar Technology **& MFG Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. DENTAL SOFT TISSUE INDICATIONS The indications are identical to the previously cleared predicate systems. Incision, excision, vaporization, ablation of oral soft tissues including marginal and inter-dental givgival and epithelial lining of free gingival and the following specific indications: - Exposure of Unerupted teeth - Fibroma removal - Frenectomy - Gingival Troughing for crown impressions - Gingivectomy - Gingivoplasty - Hemostasis and coagulation - Gingival incision and excision hemostasis - Implant recovery - Incision and drainage of abscess - Leukoplakia - Operculectomy - Oral papillectomies - Pulpotomy as an adjunct to root canal therapy - Reduction of gingival hypertrophy - Soft tissue crown lengthening - Gingival bleeding index - Excisional and incisional biopsies - Treatment of aphthous ulcer canker sores and herpetic. - Vestibuloplasty 2. LASER PERIODONTAL INDICATIONS: - Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including: probe depth, attachment loss and tooth mobility ) - Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium. 3. TOOTH WHITENING INDICATIONS - Laser Assisted whitening/bleaching of teeth. - Light activation for bleaching materials for teeth whitening. 4. PAIN INDICATIONS: - 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 minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
    Device Description
    The Zolar Technology & MFG Co. Inc. Soft Tissue Dental Laser PHOTON/PHOTON PLUS uses a solid state diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to the hand piece that emits the energy to the target site. A visible light (aiming beam) is emitted at the same time to visually assist in identifying the specific treatment location. The Photon/Photon Plus Laser Systems are comprised of a base consol, a detechable delivery system, tips and a wireless footswitch. The Photon/Photon Plus laser is intended to be used by dentist for a variety of oral soft tissue procedures
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    K Number
    K122020
    Device Name
    PHOTON PHOTON PLUS
    Manufacturer
    ZOLAR TECHNOLOGY & MFG. CO. INC.
    Date Cleared
    2013-06-05

    (330 days)

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

    **ZOLAR TECHNOLOGY **& MFG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Photon is intended for use by dentists for excision, vaporization, ablation and coagulation of oral soft tissue procedures. The specific applications are as follows: SOFT TISSUE: The metal handpiece with cutting fiber does not have any direct contact to the soft tissue, skin or cell during the operation. - . Exposure of Unerupted teeth . - . Fibroma removal - . Frenectomy - . Gingival Troughing for crown impressions - . Gingivectomy - . Gingivoplasty - . Hemostasis and coagulation - . Gingival incision and excision hemostasis - . Implant recovery - . Incision and drainage of abscess - . Leukoplakia - . Operculectomy - . Oral papillectomies - . Pulpotomy as an adjunct to root canal therapy - ' Reduction of gingival hypertrophy - . Soft tissue crown lengthening - . Gingival bleeding index - . Excisional and incisional biopsies - . Treatment of aphthous ulcer, canker sores and herpetic - . Vestibuloplasty. LASER PERIODONTAL PROCEDURES: - Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to . improve clinical indices including:, probe depth, attachment loss and tooth mobility) - Removal of highly inflamed edematous tissue affected by bacteria penetration of the . pocket lining and junctional epithelium Indications for Use for Photon Plus: The Photon Plus is intended for use by dentists for excision, vaporization, ablation and coagulation of oral soft tissue procedures. The specific applications are as follows: SOFT TISSUE: The metal handpiece with cutting fiber does not have any direct contact to the soft tissue, skin or cell during the operation. - . Exposure of Unerupted teeth - Excision of lesion or removal of Granulation tissue . - . Frenectomy - . Gingival Troughing for crown impressions - . Gingivectomy - . Gingivoplasty - . Hemostasis and coagulation - . Gingival incision and excision hemostasis - . Implant recovery - . Incision and drainage of abscess - . Leukoplakia - . Operculectomy - . Oral papillectomies - . Pulpotomy as an adjunct to root canal therapy - . Reduction of gingival hypertrophy - . Soft tissue crown lengthening - . Gingival bleeding index - Excisional and incisional biopsies . - . Treatment of aphthous ulcer, canker sores and herpetic - . Vestibuloplasty. LASER PERIODONTAL PROCEDURES: - Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including;, probe depth, attachment loss and tooth mobility) - Debridement of diseased epithelial lining . TOOTH WHITENING INDICATIONS - Laser assisted whitening/bleaching of teeth . - Light activation for bleaching materials for teeth whitening. .
    Device Description
    Photon/Photon Plus Diode Laser is a surgical device at the cutting edge of technology, designed for a wide variety of oral soft tissue and tooth whitening procedures with the wavelength of 980nm and the power range of 100mW to 10W. Photon Series Diode Laser utilizes a solid state diode a 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.
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