# K240497: Smartxide Tetra Pro

- Pathway: 510(k) (Special)
- Applicant: El.En S.P.A.
- Decided: Mar 12, 2024 after 21 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: 3 generations back to K081424 (2009). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180193: DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto), El.En Electronic Engineering Spa (2018) Summary page 5.

## 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/K240497
Methodology: https://510kreport.com/methodology