# K110333: Naturalase CO2 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Focus Medical, LLC
- Decided: Apr 12, 2012 after 434 days
- Product code: ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output)
- 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: 13 generations back to K910422 (1992). 151 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 153 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080496: Mosaic ECO2 Laser System, Lutronic Corporation (2008) Summary page 1.

## Most influential descendants
- K152529: NaturaLase CO2 Laser System (2016), 0 descendants of its own

## Indications for use
The NaturaL-ase C02 Laser System is indicated for use in dermatological procedures requiring ablation (removal), resurfacing or coagulation of soft tissue.

Source page: https://510kreport.com/device/K110333
Methodology: https://510kreport.com/methodology