Manufacturer
El.En Electronic Engineering SpaDEKA SMARTXIDE ULTRASPEED
El.En Electronic Engineering Spa
Country / Region:Italy (IT)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K172363
- Device name
- DEKA SMARTXIDE ULTRASPEED
- Country / Region
- Italy(IT)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2017-08-04
- Decision date
- 2017-11-17
- Submission type
- Traditional
- Technology type
- CO2(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
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).
Intended Use
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).
Device Description
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
Predicate devices
2—
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Not ingested
DEKA SMARTXIDE TOUCH
K172363 references 2 predicate/reference devices
Cited as predicate
1DEKA Motus AZ
1 submission cite K172363 as a predicate
