# K113504: Deka Smartxide and Delivery Accessories

- Pathway: 510(k) (Traditional)
- Applicant: El.En Electronic Engineering Spa
- Decided: Feb 1, 2013 after 431 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: 17 generations back to K943450 (1995). 352 ancestors in all.
12 later devices descend from it; 2 cite it directly.
0 of 365 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030147: Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers, Lumenis, Ltd. (2003) Summary page 1.
- K083613: Quanta System Polysurge Diode Laser Family, Quanta System Spa (2008) Summary page 1.
- K050824: 100W Ceralas D 980 Laser System, Model D100, Biolitec, Inc. (2005) Summary page 1.

## Most influential descendants
- K133895: Deka Smartxide Laser System (2014), 10 descendants of its own
- K162169: EdgeOne CO2 Laser (2016), 7 descendants of its own
- K201109: CO2 Laser Therapy System (2020), 5 descendants of its own
- K221597: CO2 Laser System (2022), 2 descendants of its own
- K241670: Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2) (2024), 1 descendant of its own

## Indications for use
The DEKA SmartXide 2 C02 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 SmartXide 2 940rnn diode laser is indicated for incision, excision, vaporization ablation and coagulation of soft tissues (open surgery), cuffing, 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 SmartXide 2 9S8rnn 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/K113504
Methodology: https://510kreport.com/methodology