510(k) · Cleared

Cleared

Trixel CO2 Laser

K110434510(k) TraditionalCleared Apr 19, 201163-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

Beijing Syntech Laser CO., LTD. · GEX Powered Laser Surgical Instrument

Cleared on Apr 19, 2011 as substantially equivalent to K101555 (Advanced Technology Laser Co., Ltd., 2010) after a 63-day review. Its family tree reaches back 5 generations to 1994. 15 later devices descend from it.

Decided: Apr 19, 2011
Review: 63 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 5 generations to K936109 (1994). 17 ancestors in all, the oldest K853620 (1986). 15 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 5 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
4 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
3 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
2 generations backK063001 Slim Evolution Family of CO2 Lasers and Delivery Device AccessoriesLasering S.R.L. · 2007
1 generation backK101555 CO2 Laser SystemAdvanced Technology Laser Co., Ltd. · 2010
This deviceK110434 Trixel CO2 LaserBeijing Syntech Laser CO., LTD. · 2011
Descendant · cites it directly · 14 of its ownK161925 CO2 Laser Therapy MachineBeijing Adss Development Co., Ltd. · 2016
Descendant · 2 generations on · 8 of its ownK192528 CO2 Laser Therapy SystemShangdong Huamei Technology Co., Ltd. · 2019
Descendant · 3 generations on · 5 of its ownK200042 CO2 Laser SystemBeijing Superlaser Technology Co., Ltd. · 2020
Descendant · 2 generations on · 2 of its ownK162398 CO2 Laser Therapy SystemsBeijing Sincoheren Science and Technology Development Co. · 2017
Descendant · 3 generations on · 1 of its ownK191518 CO2 Laser SystemShenzhen Gsd Tech Co., Ltd. · 2019

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2016high 4 (2025) · low 0 (2018)2026

Most influential descendants

Showing 5 of 15 · See all

K161925CO2 Laser Therapy MachineBeijing Adss Development Co., Ltd. · 2016 · cites it directly14descendants
K192528CO2 Laser Therapy SystemShangdong Huamei Technology Co., Ltd. · 2019 · 2 generations on8descendants
K200042CO2 Laser SystemBeijing Superlaser Technology Co., Ltd. · 2020 · 3 generations on5descendants
K162398CO2 Laser Therapy SystemsBeijing Sincoheren Science and Technology Development Co. · 2017 · 2 generations on2descendants
K191518CO2 Laser SystemShenzhen Gsd Tech Co., Ltd. · 2019 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K936109	Sharplan Model 1120 CO2 Surgical Laser	Sharplan Lasers, Inc.	1994	—
−4	K960521	Sharplan Lasers, Inc. Silktouch Flash Scanner	Sharplan Lasers, Inc.	1996	—
−3	K963339	Coherent Ultrapulse CO2 Surgical Lasers	Coherent Medical Group	1997	—
−2	K063001	Slim Evolution Family of CO2 Lasers and Delivery Device Accessories	Lasering S.R.L.	2007	—
−1	K101555	CO2 Laser System	Advanced Technology Laser Co., Ltd.	2010	—
0 (this device)	K110434	Trixel CO2 Laser	Beijing Syntech Laser CO., LTD.	2011	—
+1	K161925	CO2 Laser Therapy Machine	Beijing Adss Development Co., Ltd.	2016	—
+2	K192528	CO2 Laser Therapy System	Shangdong Huamei Technology Co., Ltd.	2019	—
+3	K200042	CO2 Laser System	Beijing Superlaser Technology Co., Ltd.	2020	—
+2	K162398	CO2 Laser Therapy Systems	Beijing Sincoheren Science and Technology Development Co.	2017	—
+3	K191518	CO2 Laser System	Shenzhen Gsd Tech Co., Ltd.	2019	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1986	1	0
1988	1	0
1990	1	0
1991	1	0
1994	2	0
1995	4	0
1996	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0
2017	1	0
2019	2	0
2020	2	0
2021	1	0
2022	1	0
2025	4	0
2026	3	0

FIG. 1 — Lineage of K110434, 1994–2026Source: 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? (1)

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
*	K101555	CO2 Laser System Summary page 2 …U.S. Agent E-mail [email protected] U.S. Agent Phone Number 608 -3355979 U.S. Agent Fax Number 760 -4665084 6. Predicate Device Identification 5 10(k) Number: K101555 Product Name: CO 2 LASER SYSTEM Manufacturer: ADVANCED TECHNOLOGY LASER CO., LTD. 7. Device Description Trixel C02 Laser…	Advanced Technology Laser Co., Ltd.	2010	—

What descends from it? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K161925	CO2 Laser Therapy Machine	Beijing Adss Development Co., Ltd.	2016	14

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 17 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
None of the 17 ancestors has a recall.
Of its descendants, K161925 (Beijing Adss Development Co., Ltd., 2016) 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. 2011, this device’s year, is highlighted.

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 equipment is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K110434 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110434: Trixel CO2 Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110434

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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