510(k) · Cleared

Cleared

Highland Beam Delivery System, Model 3-099-002-00-00

K061909510(k) TraditionalCleared Jul 19, 200613-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

Omniguide, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Jul 19, 2006 as substantially equivalent to K992472 (Clinicon Corp., 1999) and 7 other predicates after a 13-day review. Its family tree reaches back 5 generations to 1995. 2 later devices descend from it.

Decided: Jul 19, 2006
Review: 13 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 8

Its longest line of descent runs back 5 generations to K953074 (1995). 16 ancestors in all, the oldest K894762 (1989). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 5 generations backK953074 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1995
4 generations backK960475 Modified Luxar LX-20 Family CO2 Laser SystemLuxar Corp. · 1996
3 generations backK992472 Sureguide CO2 Laser Beam Delivery SystemClinicon Corp. · 1999
2 generations backK014048 Clinicon Universal Waveguide Handpiece and Fiber TipsClinicon Corp. · 2002
1 generation backK050541 Omniguide Beampath CO2 Mark I Laser Beam DeliveryOmniguide Communications, Inc. · 2005
This deviceK061909 Highland Beam Delivery System, Model 3-099-002-00-00Omniguide, Inc. · 2006
Descendant · cites it directly · 1 of its ownK063141 Omniguide Zero Flow ZF-T 150 Waveguide FiberOmniguide, Inc. · 2006
Descendant · 2 generations on · 0 of its ownK070071 Omniguide Zero Flow ZF-T Waveguide FiberOmniguide, Inc. · 2007

Most influential descendants

Showing 2 of 2 · See all

K063141Omniguide Zero Flow ZF-T 150 Waveguide FiberOmniguide, Inc. · 2006 · cites it directly1descendant
K070071Omniguide Zero Flow ZF-T Waveguide FiberOmniguide, Inc. · 2007 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K953074	Modified Luxar LX-20 Family CO2 Laser System	Luxar Corp.	1995	—
−4	K960475	Modified Luxar LX-20 Family CO2 Laser System	Luxar Corp.	1996	—
−3	K992472	Sureguide CO2 Laser Beam Delivery System	Clinicon Corp.	1999	—
−2	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	—
0 (this device)	K061909	Highland Beam Delivery System, Model 3-099-002-00-00	Omniguide, Inc.	2006	—
+1	K063141	Omniguide Zero Flow ZF-T 150 Waveguide Fiber	Omniguide, Inc.	2006	—
+2	K070071	Omniguide Zero Flow ZF-T Waveguide Fiber	Omniguide, Inc.	2007	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1989	1	0
1990	3	0
1992	1	0
1993	1	0
1994	1	0
1996	1	0
1999	1	0
2003	1	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0

FIG. 1 — Lineage of K061909, 1995–2007Source: 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? (8)

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
*	K992472	Sureguide CO2 Laser Beam Delivery System Summary page 1 …cal instrument for use in general and plastic surgery and in dermatology. Substantial Equivalence Claimed To: K992472 Clinicon SureGuide CO 2 Laser Beam Delivery System. K014048 Cli…	Clinicon Corp.	1999	—
*	K014048	Clinicon Universal Waveguide Handpiece and Fiber Tips Summary page 1 …laimed To: K992472 Clinicon SureGuide CO 2 Laser Beam Delivery System. K014048 Clinicon Universal WaveGuide Handpiece and Fiber Tips K924664 S…	Clinicon Corp.	2002	—
*	K924664	Surgilase Fiberlase CO2 Laser Waveguide Summary page 1 …System. K014048 Clinicon Universal WaveGuide Handpiece and Fiber Tips K924664 Surgilase Fiberlase CO 2 Laserwave Guide K921671 Surgilase Fiberlase V CO 2 Laser…	Surgilase, Inc.	1993	—
*	K921671	Surgilase Fiberlase VCO2 Laser Waveguide Summary page 1 …Handpiece and Fiber Tips K924664 Surgilase Fiberlase CO 2 Laserwave Guide K921671 Surgilase Fiberlase V CO 2 Laser Waveguide K896478 Luxar LX-20…	Surgical Products Corp.	1992	—
*	K896478	Luxar Model LX-20 Minilase CO2 Laser Summary page 1 …O 2 Laserwave Guide K921671 Surgilase Fiberlase V CO 2 Laser Waveguide K896478 Luxar LX-20 Minilase CO 2 Surgical Laser K031440 Cynosure Smart CO 2 Medical Laser…	Luxar Corp.	1990	—
*	K031440	Smart CO2 (Smart US 20D, Smart Clinic) Surgical Laser Summary page 1 …CO 2 Laser Waveguide K896478 Luxar LX-20 Minilase CO 2 Surgical Laser K031440 Cynosure Smart CO 2 Medical Laser System K963189 ERBE APC 300 A…	Cynosure, Inc.	2003	—
*	K963189	Erbe Apc 300 Argon Plasma Coagulator and Accessories - Argon Plasma Coagulator and… Summary page 1 …e CO 2 Surgical Laser K031440 Cynosure Smart CO 2 Medical Laser System K963189 ERBE APC 300 Argon Plasma Coagulator K050541 OmniGuide BeamPath CO 2…	Erbe USA, Inc.	1996	—
*	K050541	Omniguide Beampath CO2 Mark I Laser Beam Delivery Summary page 1 …2 Medical Laser System K963189 ERBE APC 300 Argon Plasma Coagulator K050541 OmniGuide BeamPath CO 2 Mark I Laser Beam Delivery System…	Omniguide Communications, Inc.	2005	—

Also cleared against K992472: 5 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K063141	Omniguide Zero Flow ZF-T 150 Waveguide Fiber	Omniguide, Inc.	2006	1

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 11 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
None of the 16 ancestors has a recall.
Of its descendants, K063141 (Omniguide, Inc., 2006) has gone furthest, with 1 descendant of its own.
5 other devices also cite its predicate K992472.

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 OmniGuide's Highland Beam Delivery System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intraorat tissues, in the medical specialties of general and plastic surgery, oral / maxittofaciat surgery, dentistry, dermatology, endoscopic surgical procedures related to gynecology, otorhinotaryngotogy, neurosurgery, gastroenterology, and pulmonary surgery for surgical and aesthetic applications. The indications for use for which the device is used are also dependant upon the cleared indications for use of the laser system and the laser system accessories to which it is attached.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K061909 · printed Nov 4, 2026

Cite this page

510(k) Report. “K061909: Highland Beam Delivery System, Model 3-099-002-00-00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061909

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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