# K152529: NaturaLase CO2 Laser System

- Pathway: 510(k) (Abbreviated)
- Applicant: Focus Medical, LLC
- Decided: Feb 4, 2016 after 154 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: 15 generations back to K910422 (1992). 158 ancestors in all.
No later device cites it as a predicate yet.
0 of 159 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110333: Naturalase CO2 Laser System, Focus Medical, LLC (2012) Summary page 4.
- K123573: Youlaser CO2 Laser, Quanta System Spa (2013) Summary page 4.

## Indications for use
NaturaLase CO2 laser operating in traditional non-fractionated mode is 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), gynecology, urology, neurosurgery, dental and oral surgery and genitourinary surgery. NaturaLase CO2 laser operating in fractional mode is indicated for ablative skin resurfacing.

Source page: https://510kreport.com/device/K152529
Methodology: https://510kreport.com/methodology