510(k) · Cleared

Cleared

C4

K970143510(k) TraditionalCleared Oct 29, 1997287-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Clinicon Corp. · GEX Powered Laser Surgical Instrument

Cleared on Oct 29, 1997 as substantially equivalent to K963229 (Sharplan Lasers, Inc., 1996) and 1 other predicate after a 287-day review. Its family tree reaches back 1 generation to 1991.

Decided: Oct 29, 1997
Review: 287 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K913606 (1991). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK913606 Chrys XX CO2 Surgical Laser SystemJamar Medical Systems · 1991
This deviceK970143 C4Clinicon Corp. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K913606	Chrys XX CO2 Surgical Laser System	Jamar Medical Systems	1991	—
0 (this device)	K970143	C4	Clinicon Corp.	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

FIG. 1 — Lineage of K970143, 1991–1997Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEX device

#1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K963229	Sharplan Models 20C, 30C, and 40C CO2 Lasers Summary page 1 …n: Alan Bunting Date prepared: January 9, 1997 Trade name: C* Common name: Laser Classification name: Class II Substantial equivalence claimed to: 1. Sharplan 20C - K963229 2. JMED CHRYS - K913606 3. Surgical Laser Specialties Ultra MD Laser - 510k Number Unknown Description: The Clinicon C* CO, la…	Sharplan Lasers, Inc.	1996	—
*	K913606	Chrys XX CO2 Surgical Laser System Summary page 1 …pared: January 9, 1997 Trade name: C* Common name: Laser Classification name: Class II Substantial equivalence claimed to: 1. Sharplan 20C - K963229 2. JMED CHRYS - K913606 3. Surgical Laser Specialties Ultra MD Laser - 510k Number Unknown Description: The Clinicon C* CO, laser is a sealed, liquid -…	Jamar Medical Systems	1991	—
*	—	Surgical Laser Specialties Ultra MD Laser Named without a submission number			—

Also cleared against K963229: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
6 other devices also cite its predicate K963229.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEX

83in 2025

2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	73	79	9	342
2008	107	86	2	232
2009	69	100	0	209
2010	50	96	4	1,711
2011	41	83	18	3,024
2012	45	118	5	2,000
2013	46	144	3	2,236
2014	61	147	6	2,036
2015	47	112	0	2,099
2016	51	114	1	2,585
2017	67	90	5 (1)	2,977
2018	51	78	5	3,525
2019	41	88	6	2,709
2020	52	90	1	2,183
2021	53	123	0	3,465
2022	60	152	0	2,288
2023	52	87	6	2,337
2024	82	90	3	2,187
2025	83	90	0	2,720
2026	57	90	2	—

What is it indicated for?

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…

Read the full statement (142 words)

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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K970143 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970143: C4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970143

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026

C4