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510(k) Data Aggregation
K Number
K211150Device 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
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Soga Technology Co., Ltd.
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
K214008Device Name
Dental diode laser
Manufacturer
Shenzhen Soga Technology Co., Ltd.
Date Cleared
2022-05-10
(139 days)
Product Code
NVK, GEX, PRI
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Soga Technology Co., Ltd.
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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