# K172362: Deka Smartxide Touch

- 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 K081424 (2009). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081424: Affirm CO2 and Affirm CO2 HP, Cynosure, Inc. (2009) Summary page 4.

## Most influential descendants
- K180193: DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) (2018), 1 descendant of its own
- K240497: Smartxide Tetra Pro (2024), 0 descendants of its own

## Indications for use
Incision, excision, ablation, vaporization, and coagulation of body soft tissue including intraoral tissue, in medical specialities including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery, 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/K172362
Methodology: https://510kreport.com/methodology