Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
810 nm Diode Laser System: * Incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following: ° 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 removal of diseased, infected, 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 ¢ Surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, ophthalmology, and pulmonology 810 nm Diode Laser Module: * Incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following: ° Gingival troughing for crown impression ° Gingivoplasty ° Soft tissue crown lengthening ° Treatment of aphthous ulcers ° Treatment of herpetic lesions 810 nm Diode Laser System & Module 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. 980 nm Diode Laser: ¢ Gingival troughing * Crown lengthening ¢ Gingivoplasty * Coagulation * Hemostasis of donor site ¢ Implant recovery ¢ Implant uncovery * Soft tissue curettage ¢ Sulcular debridement * Biopsy ¢ Frenectomy * Operculectomy ¢ Exposure of unerupted teeth * Pulpotomy ¢ Treatment of aphthous ulcers ¢ Excision of lesions ¢ Light activation of bleaching materials for teeth whitening ¢ Surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, genitourinary, gynecology, neurosurgery, otolaryngology, orthopedics, ophthalmology, pulmonology, and thoracic surgery. 445 nm Diode Laser: ¢ Incision/excision, vaporization, ablation, hemostasis and coagulation of soft tissue Type of Use (Select one or both, as applicable) Xx Prescription Use (Part 21 CFR 801 Subpart D) [_] Over-The-Counter Use (21 CFR 801 Subpart C)
810 nm Diode Laser System: * Incision, excision, vaporization, ablation and coagulation of oral soft tissues including the following: ° 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 removal of diseased, infected, 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 * Surgical applications requiring the ablation, vaporization, excision, incision, hemostasis, or coagulation of soft tissues in medical specialties including dermatology, dentistry, gastroenterology, general surgery, neurosurgery, otolaryngology, ophthalmology, and pulmonology
The Fotona XPulse Pro Laser Platform is a multi-application, multi-technology platform that supports the diode laser technology. A diode aiming beam is combined with all therapeutic laser beams. The combined therapeutic and aiming beams are guided through an optical fiber delivery system to an optical handpiece or to the bare fiber distal end. The Fotona XPulse Pro Laser Platform consists of a console, a footswitch and attachable laser modules. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system micro-controller through an LCD touch-screen. The following wavelengths are currently available with the XPulse platform: 445 nm, 810 nm and 980 nm. Following handpieces are to be used with Fotona Xpulse Pro Laser Platform: R21-SHP, R26 (variants: black, green, blue, silver and red), R24, R30, Genova and MarcCo (variants S, M & L).
Summary parsed at:2026-06-01 05:42:02 UTC
