Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
Dental 5 Diode laser system is indicated for the Incision, Ablation, Vaporization and Hemostasis of oral soft tissue such as, Excisional and Incisional biopsies, Exposure of Unerupted teeth, Fibroma Removal, Frenectomy and Frenotomy, Gingival troughing for crown impressions, Gingivectomy, Gingivoplasty, Gingival Incision and Excision, 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, Sulcular debridement, Treatment of aphthous ulcers, Vestibuloplasty, Biopsy incision and excision, lesion (tumor) removal, light activation for bleaching material, for laser assisted bleaching/whitening for teeth.
Dental 5 Diode laser system is indicated for the Incision, Ablation, Vaporization and Hemostasis of oral soft tissue such as, Excisional and Incisional biopsies, Exposure of Unerupted teeth, Fibroma Removal, Frenectomy and Frenotomy, Gingival troughing for crown impressions, Gingivectomy, Gingvioplasty, Gingivar Incision and Excision, 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, Sulcular debridement, Treatment of aphthous ulcers, Vestibuloplasty, Biopsy incision and excision, lesion (tumor) removal, light activation for bleaching material, for laser assisted bleaching/whitening for teeth.
Dental 5 multi Diode laser system are producing 810 I 980+-1Onm wave length Solid state Grallium Aluminum Arsenide (GaAIAs) semiconductor diode invisible infrared radiation as a laser energy, and also available switchable 650nm aiming beam with 5-7watts, the laser power is delivered to the treatment area via a fiber bendable optic tip to access all areas of the mouth. The Physician can optimize the effect for different applications by controlling the energy of the laser pulse and the treatment beam and it is able to activate laser emission using foot pedal switch. Laser parameters and other system features are controlled from a display panel located on the front of the power supply unit. The delivery system consists of Autoclavable hand piece and foot pedal switch.
Summary parsed at:2026-06-01 05:59:21 UTC
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