# K014236: Clinicon Waveguide Platform with Interconnect for Luxar Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Clinicon Corp.
- Decided: Mar 26, 2002 after 90 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: 3 generations back to K953074 (1995). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992472: Sureguide CO2 Laser Beam Delivery System, Clinicon Corp. (1999) Summary page 1.
- K960475: Modified Luxar LX-20 Family CO2 Laser System, Luxar Corp. (1996) Summary page 1.

## Indications for use
The intended use of the Clinicon WaveGuide Platform is to deliver carbon dioxide laser energy from a CO, laser source to a CO, laser accessory, with minimal beam degradation. The waveguide platform can be used with various manufacturers’ CO, lasers and laser accessories, including Clinicon accessories. The specific indications are dependent upon the cleared indications for use of the laser system and laser accessories to which the waveguide platform is attached. The Clinicon Interconnect enables Luxar accessories that are designed to be used with the standard Luxar cables to be connected with the Clinicon WaveGuide Platform.

Source page: https://510kreport.com/device/K014236
Methodology: https://510kreport.com/methodology