510(k) · Cleared

Cleared

Clinicon Universal Waveguide Handpiece and Fiber Tips

K014048510(k) TraditionalCleared Feb 11, 200266-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 Feb 11, 2002 as substantially equivalent to K903079 (Luxar Corp., 1990) and 1 other predicate after a 66-day review. Its family tree reaches back 3 generations to 1995. 15 later devices descend from it.

Decided: Feb 11, 2002
Review: 66 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K953074 (1995). 5 ancestors in all, the oldest K903079 (1990). 15 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 3 generations backK953074 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1995
2 generations backK960475 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1996
1 generation backK992472 Sureguide CO2 Laser Beam Delivery SystemClinicon Corp. · 1999
This deviceK014048 Clinicon Universal Waveguide Handpiece and Fiber TipsClinicon Corp. · 2002
Descendant · cites it directly · 14 of its ownK050541 Omniguide Beampath CO2 Mark I Laser Beam DeliveryOmniguide Communications, Inc. · 2005
Descendant · 2 generations on · 8 of its ownK070157 Omniguide Beam Path CO2 Mark Iii Waveguide FiberOmniguide, Inc. · 2007 · Recalled
Descendant · 2 generations on · 5 of its ownK073313 Mark Iii Waveguide Fiber with Low Profile TipOmniguide, Inc. · 2008
Descendant · 3 generations on · 4 of its ownK093451 Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low…Omniguide, Inc. · 2009
Descendant · 3 generations on · 2 of its ownK140378 Flexguide Ultra Beampath Robotic Fiber ConduitOmniguide, Inc. · 2014

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2005high 3 (2006) · low 0 (2010)2026

Most influential descendants

Showing 5 of 15 · See all

K050541Omniguide Beampath CO2 Mark I Laser Beam DeliveryOmniguide Communications, Inc. · 2005 · cites it directly14descendants
K070157Omniguide Beam Path CO2 Mark Iii Waveguide FiberOmniguide, Inc. · 2007 · 2 generations on8descendants
K073313Mark Iii Waveguide Fiber with Low Profile TipOmniguide, Inc. · 2008 · 2 generations on5descendants
K093451Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low Loss TipOmniguide, Inc. · 2009 · 3 generations on4descendants
K140378Flexguide Ultra Beampath Robotic Fiber ConduitOmniguide, Inc. · 2014 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K953074	Modified Luxar LX-20 Family CO2 Laser System	Luxar Corp.	1995	—
−2	K960475	Modified Luxar LX-20 Family CO2 Laser System	Luxar Corp.	1996	—
−1	K992472	Sureguide CO2 Laser Beam Delivery System	Clinicon Corp.	1999	—
0 (this device)	K014048	Clinicon Universal Waveguide Handpiece and Fiber Tips	Clinicon Corp.	2002	—
+1	K050541	Omniguide Beampath CO2 Mark I Laser Beam Delivery	Omniguide Communications, Inc.	2005	—
+2	K070157	Omniguide Beam Path CO2 Mark Iii Waveguide Fiber	Omniguide, Inc.	2007	1
+2	K073313	Mark Iii Waveguide Fiber with Low Profile Tip	Omniguide, Inc.	2008	—
+3	K093451	Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low Loss Tip	Omniguide, Inc.	2009	—
+3	K140378	Flexguide Ultra Beampath Robotic Fiber Conduit	Omniguide, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	3	0
2007	3	0
2008	1	0
2009	1	0
2011	1	0
2014	1	0
2017	1	0
2021	3	0

FIG. 1 — Lineage of K014048, 1995–2021Source: 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

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What was it cleared against? (2)

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
*	K903079	Endoguide (R), Microguide (TM), Flexiguide (TM) Summary page 1 …8.4810 Product Code: GEX Classification name: Laser surgical instrument for use in general and plastic surgery and in dermatology. Substantial equivalence claimed to: K903079, Luxar’s Endoguide ®, Microguide ™, Flexiguide™ K992472, Clinicon’s SureGuide CO2 Laser Beam Delivery System Description: The U…	Luxar Corp.	1990	—
*	K992472	Sureguide CO2 Laser Beam Delivery System Summary page 1 …rgical instrument for use in general and plastic surgery and in dermatology. Substantial equivalence claimed to: K903079, Luxar’s Endoguide ®, Microguide ™, Flexiguide™ K992472, Clinicon’s SureGuide CO2 Laser Beam Delivery System Description: The Universal WaveGuide Handpiece comes in two designs, one t…	Clinicon Corp.	1999	—

What descends from it? (15)

See all 15

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K050541	Omniguide Beampath CO2 Mark I Laser Beam Delivery	Omniguide Communications, Inc.	2005	14
K061909	Highland Beam Delivery System, Model 3-099-002-00-00	Omniguide, Inc.	2006	2

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?

The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
None of the 5 ancestors has a recall.
Of its descendants, K050541 (Omniguide Communications, Inc., 2005) has gone furthest, with 14 descendants of its own.

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?

The Clinicon UHP/disposable tip is/are indicated for use in general and plastic surgery,

neurosurgery, ophthalmology, oral surgery, oto-rhino-laryngology, podiatry, gynecology,

and urology procedures for incision, excision, vaporization, ablation, coagulation,

cauterization of soft tissue.

The Clinicon UHP/disposable tip indications are dependent upon the cleared indications

for use of the laser system and laser system accessories to which it is attached.

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/K014048 · printed Nov 6, 2026

Cite this page

510(k) Report. “K014048: Clinicon Universal Waveguide Handpiece and Fiber Tips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K014048

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026