# K031224: Smartxide

- Pathway: 510(k) (Special)
- Applicant: Cynosure, Inc.
- Decided: May 9, 2003 after 22 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.
33 later devices descend from it; 3 cite it directly.
0 of 34 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) PhotoAppeal laser: named in the summary without a submission number

## Most influential descendants
- K080496: Mosaic ECO2 Laser System (2008), 30 descendants of its own
- K091115: ECO2 Laser System (2009), 27 descendants of its own
- 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

## Indications for use
The Smart CO, surgical lasers are indicated for incision, excision, and coagulation of body soft tissuc. It's typical applications include dermatology, plastic surgery, urology, gastroenterology, neurosurgery, gynecology and gcneral surgery.

Source page: https://510kreport.com/device/K031224
Methodology: https://510kreport.com/methodology