# K240537: Smartxide Pro

- Pathway: 510(k) (Special)
- Applicant: El.En S.P.A.
- Decided: Mar 20, 2024 after 23 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 K072159 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072159: Smart CO2 (Smartxide, Smart US20D) with Dot Scanner, El.En Electronic Engineering Spa (2007) Summary page 5.

## Indications for use
The SMARTXIDE PRO is a medical device indicated for 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, 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/K240537
Methodology: https://510kreport.com/methodology