# K121580: Surelase CO2 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Clinicon Corp.
- Decided: Sep 25, 2012 after 118 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: 1 generation back to K953074 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953074: Modified Luxar LX-20 Family CO2 Laser System, Luxar Corp. (1995) Summary page 3.
- K072159: Smart CO2 (Smartxide, Smart US20D) with Dot Scanner, El.En Electronic Engineering Spa (2007) Summary page 3.

## Indications for use
The Clinicon SureLase CO 2 Laser System is intended for use in laser surgery procedures for incision, excision, vaporization, ablation, coagulation, or cauterization in specialties such as: general surgery, cosmetic surgery, dermatology, gynecology, head & neck surgery, neurosurgery, oral surgery, otorhinolaryngology, pediatric surgery, plastic & reconstructive surgery, podiatry, and urology.

Source page: https://510kreport.com/device/K121580
Methodology: https://510kreport.com/methodology