El.En Electronic Engineering Spa
Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The SmartXide UltraSpeed laser is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, endoscopic/laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications. Also, the SmartXide UltraSpeed laser is indicated for periodontal applications such as, but not limited to: • Removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement) • Biopsies • Frenectomy, Frenum release • Gingivoplasty • Papillectomy • Vestibuloplasty • Hyperplasia • Operculectomy • Drainage (abscess) • Flap surgery • Fibroma (nonmalignant tumor, mucosa, tongue) • Epulis • Aphthous ulcers • Removal of soft tissue, cysts, and tumors • Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium).
The SmartXide UltraSpeed laser is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, endoscopic/laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications. Also, the SmartXide UltraSpeed laser is indicated for periodontal applications such as, but not limited to: Removal of diseased or Inflamed soft tissue in the periodontal pocket (sulcular debridement), Biopsies, Frenectomy, Frenum release, Gingivoplasty, Papillectomy, Vestibuloplasty, Hyperplasia, Operculectomy, Drainage (abscess), Flap surgery, Fibroma (nonmalignant tumor, mucosa, tongue), Epulis, Aphthous ulcers, Removal of soft tissue, cysts, and tumors, Laser assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium).
DEKA SmartXide UltraSpeed is a 10,600 nm CO2 laser device with a maximum power of 40W. The laser source delivers the laser output through interchangeable laser handpieces. Handpiece activation is by footswitch.
Summary parsed at:2026-06-01 06:00:44 UTC
