# K101904: Smartxide 50 HS/MS

- Pathway: 510(k) (Traditional)
- Applicant: El.En Electronic Engineering Spa
- Decided: Jan 12, 2011 after 188 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: 7 generations back to K936109 (1994). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082809: Acupulse 30 and 40 Carbon Dioxide Laser System, Lumenis, Inc. (2008) Summary page 1.
- K072159: Smart CO2 (Smartxide, Smart US20D) with Dot Scanner, El.En Electronic Engineering Spa (2007) Summary page 2.
- K030147: Lumenis Family of Ultrapulse Surgitouch CO2 Surgical Lasers, Lumenis, Ltd. (2003) Summary page 2.

## Indications for use
The Smartfide 50 ES/MS system with its delivery accessories is a medical device indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otolaryngology (ENT), gynaecology, neurosurgery and genitourinary surgery.

Source page: https://510kreport.com/device/K101904
Methodology: https://510kreport.com/methodology