# K181867: Deka Smartxide2 Trio

- Pathway: 510(k) (Special)
- Applicant: El.En Electronic Engineering Spa
- Decided: Oct 2, 2018 after 82 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: 18 generations back to K943450 (1995). 353 ancestors in all.
No later device cites it as a predicate yet.
0 of 354 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113504: Deka Smartxide and Delivery Accessories, El.En Electronic Engineering Spa (2013) Summary page 4.

## Indications for use
The DEKA SmartXide2 Trio CO2 laser is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The DEKA Smartxide2 Trio 940nm diode laser is indicated for incision, excision, vaporization ablation and coagulation of soft tissues (open surgery), cutting, vaporization, ablation and coagulation of soft tissues (endoscopic surgery) in medical specialties including: plastic surgery, dermatology, ENT, gynaecology, urology, general surgery, gastroenterology and dental procedures. The DEKA SmartXide2 Trio 980nm diode laser is indicated for incision, excision, vaporization ablation and coagulation of soft tissues (open and endoscopic surgery) in medical specialties including plastic surgery, dermatology, ear, nose and throat and oral surgery (otolaryngology), gynaecology, urology, neurosurgery, general and thoracic surgery, gastroenterology and dental procedures.

Source page: https://510kreport.com/device/K181867
Methodology: https://510kreport.com/methodology