510(k) · Cleared

Cleared

Clarus Straight Firing Laser Fiber; Clarus Side Firing Laser Fiber; Models 1150, 1160

K021848510(k) TraditionalCleared Sep 3, 200290-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 Sep 3, 2002 as substantially equivalent to K922881 (Clarus Medical Systems, Inc., 1992) and 4 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1992.

Decided: Sep 3, 2002
Review: 90 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. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK922881 Clarus Models 1100, 1101, 1102, 1103 Laser DiscClarus Medical Systems, Inc. · 1992 · Recalled
This deviceK021848 Clarus Straight Firing Laser Fiber; Clarus Side Firing Laser Fiber…Clarus Medical, LLC · 2002

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)	K021848	Clarus Straight Firing Laser Fiber; Clarus Side Firing Laser Fiber; Models…	Clarus Medical, LLC	2002	—

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

FIG. 1 — Lineage of K021848, 1992–2002Source: 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 …Classification Name: Laser surgical instrument for use in gcncral and plastic surgery and in dermatology. I’redicatc Dcvices: K92288 1 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 …2288 1 Model 1 150 Laser Fiber Clarus Medical, LLC KO1 1207 Reusable Holmium Fiber Laser Peripherals K973 172 Resposable 1Holmium Bare Fibers Tr i M edy ne, 1IIC . K992083 Scattcr Free 12ateralEmitting…	Trimedyne, Inc.	1998	—
*	K992083	Scatterfree Lateral Emitting Fiber Summary page 1 …1207 Reusable Holmium Fiber Laser Peripherals K973 172 Resposable 1Holmium Bare Fibers Tr i M edy ne, 1IIC . K992083 Scattcr Free 12ateralEmitting Fibcr Laser Peripherals K972272 Laser I’eriphcrals Holmium Bare F…	Laser Peripherals, LLC	1999	—
*	K972272	Laser Peripherals Holmium Bare Fibers Summary page 1 …172 Resposable 1Holmium Bare Fibers Tr i M edy ne, 1IIC . K992083 Scattcr Free 12ateralEmitting Fibcr Laser Peripherals K972272 Laser I’eriphcrals Holmium Bare Fibcrs 1,ascr Peripherals Intended U s z ‘I’lieClarus Model 1 150 Straight…	Laser Peripherals, LLC	1997	—

Also cleared against K922881: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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.
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 Straight Firing Laser Fiber and the Clarus Side Firing Lasers Fiber are for use in general, urological, OB-GYN, orthopedic, 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/K021848 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021848: Clarus Straight Firing Laser Fiber; Clarus Side Firing Laser Fiber; Models 1150, 1160.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021848

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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