510(k) · Cleared

Cleared

Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser Fiber, Model 1160

K022610510(k) TraditionalCleared Nov 5, 200291-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

Clarus Medical, LLC · GEX Powered Laser Surgical Instrument

Cleared on Nov 5, 2002 as substantially equivalent to K922881 (Clarus Medical Systems, Inc., 1992) and 4 other predicates after a 91-day review. Its family tree reaches back 1 generation to 1992. 19 later devices descend from it.

Decided: Nov 5, 2002
Review: 91 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K922881 (1992). 5 ancestors in all. 19 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK922881 Clarus Models 1100, 1101, 1102, 1103 Laser DiscClarus Medical Systems, Inc. · 1992 · Recalled
This deviceK022610 Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing…Clarus Medical, LLC · 2002
Descendant · cites it directly · 18 of its ownK040424 Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous…Clarus Medical, LLC · 2004 · Recalled
Descendant · 2 generations on · 17 of its ownK040919 Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 2004 · Recalled
Descendant · 3 generations on · 14 of its ownK062038 X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006
Descendant · 4 generations on · 13 of its ownK093062 Vertos Medical Mild Device KitX-Sten Corp. · 2010
Descendant · 5 generations on · 7 of its ownK180876 DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2004high 4 (2026) · low 0 (2005)2026

Most influential descendants

Showing 5 of 19 · See all

K040424Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model…Clarus Medical, LLC · 2004 · cites it directly18descendants
K040919Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 2004 · 2 generations on17descendants
K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006 · 3 generations on14descendants
K093062Vertos Medical Mild Device KitX-Sten Corp. · 2010 · 4 generations on13descendants
K180876DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018 · 5 generations on7descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K922881	Clarus Models 1100, 1101, 1102, 1103 Laser Disc	Clarus Medical Systems, Inc.	1992	1
0 (this device)	K022610	Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser…	Clarus Medical, LLC	2002	—
+1	K040424	Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy…	Clarus Medical, LLC	2004	1
+2	K040919	Nucleotome Probe Set, Model 21200	Clarus Medical, LLC	2004	1
+3	K062038	X-Sten Mild Tool Kit, Model MTK-0001	X-Sten Corp.	2006	—
+4	K093062	Vertos Medical Mild Device Kit	X-Sten Corp.	2010	—
+5	K180876	DTRAX Spinal System	Providence Medical Technology, Inc.	2018	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
1999	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2006	1	0
2009	2	0
2010	1	0
2012	1	0
2018	1	0
2019	1	0
2021	1	0
2024	2	0
2025	3	0
2026	4	0

FIG. 1 — Lineage of K022610, 1992–2026Source: 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

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What was it cleared against? (5)

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
*	K922881	Clarus Models 1100, 1101, 1102, 1103 Laser Disc Summary page 1 …nd plastic surgery and in dermatology. Predicate Devices: 51 O(k) Number Description Manufacturer K922881 Model 1 150 Laser Fiber Clarus Medical, LLC KO1 1207 Reusable Holmium Fiber…	Clarus Medical Systems, Inc.	1992	1
*	K011207	Laser Peripherals Reusable Holmium Fiber	Laser Peripherals, LLC	2001	—
*	K973172	Resposable Bare Fibers Summary page 1 …K922881 Model 1 150 Laser Fiber Clarus Medical, LLC KO1 1207 Reusable Holmium Fiber Laser Peripherals K973 172 Resposable Holmium Bare Fibers Trimedyne, Inc. K992083 Scatter Free Lateral Emitting Fiber…	Trimedyne, Inc.	1998	—
*	K992083	Scatterfree Lateral Emitting Fiber Summary page 1 …LC KO1 1207 Reusable Holmium Fiber Laser Peripherals K973 172 Resposable Holmium Bare Fibers Trimedyne, Inc. K992083 Scatter Free Lateral Emitting Fiber Laser Peripherals K972272 Laser Peripherals Holmium Bare Fiber…	Laser Peripherals, LLC	1999	—
*	K972272	Laser Peripherals Holmium Bare Fibers Summary page 1 …ls K973 172 Resposable Holmium Bare Fibers Trimedyne, Inc. K992083 Scatter Free Lateral Emitting Fiber Laser Peripherals K972272 Laser Peripherals Holmium Bare Fibers Laser Peripherals Intended Use: The Clarus Model 1 150 Straight Firin…	Laser Peripherals, LLC	1997	—

Also cleared against K922881: 2 other devices →

What descends from it? (19)

See all 19

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

Number	Device	Applicant	Decided	Descendants
K040424	Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model…	Clarus Medical, LLC	2004	18

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?

1 of the 5 ancestors has a recall of any class.
Of its descendants, K040424 (Clarus Medical, LLC, 2004) has gone furthest, with 18 descendants of its own.
2 other devices also cite its predicate K922881.

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 Clarus Model 1150 Straight Firing Laser is for use in general, urological, OB-GYN, orthopedic (including lumbar and cervical), and ENT laser surgical procedures for cutting, vaporizing, or coagulating in any soft tissue application for which Ho:YAG lasers have been cleared.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022610 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022610: Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser Fiber, Model 1160.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022610

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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