# K970143: C4

- Pathway: 510(k) (Traditional)
- Applicant: Clinicon Corp.
- Decided: Oct 29, 1997 after 287 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 K913606 (1991). 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)
- K963229: Sharplan Models 20C, 30C, and 40C CO2 Lasers, Sharplan Lasers, Inc. (1996) Summary page 1.
- K913606: Chrys XX CO2 Surgical Laser System, Jamar Medical Systems (1991) Summary page 1.
- (no number) Surgical Laser Specialties Ultra MD Laser: named in the summary without a submission number

## Indications for use
For use in vaporization, incision and excision of soft tissue in dermatology, general surgery, neurosurgery, oral surgery, oto-rhino-laryngology, and podiatry. The Clinicon C* CO, laser is a sealed, liquid and convection cooled carbon dioxide surgical laser that is DC excited. The output of the laser is a concentrated beam of invisible infrared light at 10.6 micrometer wavelength. The laser has an output power range of 0-25 watts delivered to tissue. The laser system is fitted with a surgical hand piece as a standard accessory, producing a collimated beam with a spot size of 200 microns. The hand-pieces sold with this device will be of the same design and configuration but will have various tip sizes and focal lengths. These hand pieces are only intended for open surgery procedures in the non-contact mode. The hand piece is manufactured from 304 surgical stainless steel.

Source page: https://510kreport.com/device/K970143
Methodology: https://510kreport.com/methodology