# K172363: Deka Smartxide Ultraspeed

- Pathway: 510(k) (Traditional)
- Applicant: El.En Electronic Engineering Spa
- Decided: Nov 17, 2017 after 105 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K081181 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081181: Smart CO2 (Smart US 20D / Ultraspeed, Smart Clinic and Periopulse) Surgical Laser, Cynosure, Inc. (2008) Summary page 4.

## 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 urgery, 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).

Source page: https://510kreport.com/device/K172363
Methodology: https://510kreport.com/methodology