510(k) · Cleared

Cleared

Smart CO2 (Smart US 20D, Smart Clinic) Surgical Laser

K031440510(k) TraditionalCleared Oct 1, 2003148-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

Cynosure, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Oct 1, 2003 after a 148-day review. The FDA summary names its predicate without a number. 18 later devices descend from it.

Decided: Oct 1, 2003
Review: 148 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 0

18 later devices descend from it, 4 citing it directly.

This deviceK031440 Smart CO2 (Smart US 20D, Smart Clinic) Surgical LaserCynosure, Inc. · 2003
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 18 descendants. See all descendants

Descendants cleared per year

2004high 4 (2006) · low 0 (2010)2026

Most influential descendants

Showing 5 of 18 · 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
0 (this device)	K031440	Smart CO2 (Smart US 20D, Smart Clinic) Surgical Laser	Cynosure, Inc.	2003	—
+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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2006	4	0
2007	3	0
2008	1	0
2009	1	0
2011	1	0
2012	1	0
2014	1	0
2017	1	0
2021	3	0

FIG. 1 — Lineage of K031440, 2003–2021Source: 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
*	—	Luxar NovaPulse Named without a submission number			—
*	—	Asclepion Multipulse laser Named without a submission number			—

What descends from it? (18)

See all 18

4 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
K042439	Azuryt Model CLT 1401, CO2 Surgical Laser System	Diamond Age Systems, Inc.	2004	1
K120932	Opelaser Pro II and the Opelaser Lite II	The Yoshida Dental Mfg. Co., Ltd.	2012	0

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?

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 Smart CO₂ surgical laser is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology for surgical and aesthetic applications.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031440 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031440: Smart CO2 (Smart US 20D, Smart Clinic) Surgical Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031440

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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