# K133895: Deka Smartxide Laser System

- Pathway: 510(k) (Traditional)
- Applicant: El.En S.P.A.
- Decided: Sep 5, 2014 after 259 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). 354 ancestors in all.
10 later devices descend from it; 3 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)
- K113504: Deka Smartxide and Delivery Accessories, El.En Electronic Engineering Spa (2013) Summary page 4.
- K081424: Affirm CO2 and Affirm CO2 HP, Cynosure, Inc. (2009) Summary page 4.

## Most influential descendants
- 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
- K150587: Cortex Laser System (2015), 1 descendant of its own

## Indications for use
It 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 thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.

Source page: https://510kreport.com/device/K133895
Methodology: https://510kreport.com/methodology