# K072159: Smart CO2 (Smartxide, Smart US20D) with Dot Scanner

- Pathway: 510(k) (Traditional)
- Applicant: El.En Electronic Engineering Spa
- Decided: Dec 27, 2007 after 143 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
No predicates in its family tree.
32 later devices descend from it; 6 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Lumenis UltraPulse Encore lasers and delivery device accessories: named in the summary without a submission number

## Most influential descendants
- K123573: Youlaser CO2 Laser (2013), 19 descendants of its own
- K160312: Fraxis Duo (2016), 14 descendants of its own
- K170325: Secret RF (2017), 10 descendants of its own
- K123037: Lightscalpel (2012), 4 descendants of its own
- K210084: Silkro (2022), 3 descendants of its own

## Indications for use
The smart CO2 (SmartXide and Smart US20D) Lasers with DOT scanner are 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/K072159
Methodology: https://510kreport.com/methodology