510(k) · Cleared
Recalled · Class II · 2021Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model 1120
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clarus Medical, LLC · GEX Powered Laser Surgical Instrument
Cleared on May 11, 2004 as substantially equivalent to K922881 (Clarus Medical Systems, Inc., 1992) and 2 other predicates after an 83-day review. Its family tree reaches back 2 generations to 1992. 18 later devices descend from it. It has been recalled once.
- Decided
- May 11, 2004
- Review
- 83 days
- Class
- Class II
- Product code
- GEX
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 2 generations to K922881 (1992). 7 ancestors in all. 18 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK922881 Clarus Models 1100, 1101, 1102, 1103 Laser DiscClarus Medical Systems, Inc. · 1992 · Recalled
- 1 generation backK022610 Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing…Clarus Medical, LLC · 2002
- This deviceK040424 Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous…Clarus Medical, LLC · 2004
- Descendant · cites it directly · 17 of its ownK040919 Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 2004 · Recalled
- Descendant · 2 generations on · 14 of its ownK062038 X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006
- Descendant · 3 generations on · 13 of its ownK093062 Vertos Medical Mild Device KitX-Sten Corp. · 2010
- Descendant · 4 generations on · 7 of its ownK180876 DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018
- Descendant · 5 generations on · 6 of its ownK190201 CORUS Spinal SystemProvidence Medical Technology, Inc. · 2019
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K040919Nucleotome Probe Set, Model 21200Clarus Medical, LLC · 2004 · cites it directly17descendants
- K062038X-Sten Mild Tool Kit, Model MTK-0001X-Sten Corp. · 2006 · 2 generations on14descendants
- K093062Vertos Medical Mild Device KitX-Sten Corp. · 2010 · 3 generations on13descendants
- K180876DTRAX Spinal SystemProvidence Medical Technology, Inc. · 2018 · 4 generations on7descendants
- K190201CORUS Spinal SystemProvidence Medical Technology, Inc. · 2019 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K922881 | Clarus Models 1100, 1101, 1102, 1103 Laser Disc | Clarus Medical Systems, Inc. | 1992 | 1 |
| −1 | K022610 | Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser… | Clarus Medical, LLC | 2002 | — |
| 0 (this device) | K040424 | Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy… | Clarus Medical, LLC | 2004 | — |
| +1 | K040919 | Nucleotome Probe Set, Model 21200 | Clarus Medical, LLC | 2004 | 1 |
| +2 | K062038 | X-Sten Mild Tool Kit, Model MTK-0001 | X-Sten Corp. | 2006 | — |
| +3 | K093062 | Vertos Medical Mild Device Kit | X-Sten Corp. | 2010 | — |
| +4 | K180876 | DTRAX Spinal System | Providence Medical Technology, Inc. | 2018 | — |
| +5 | K190201 | CORUS Spinal System | Providence Medical Technology, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 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 |
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
What was it cleared against? (3)
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 | Decided |
|---|---|---|---|
| * | K922881 | Clarus Models 1100, 1101, 1102, 1103 Laser DiscSummary page 1…assification Name: Laser Inistrument, Surgical, Powered; 878.481 0 P~redicate Devices: 51 ~k) Descrivtion Mlanufacturer K922881 Model 1100 Laser Endoscopic Decompression Kit Clarus Medical, LLC K01I 1454 Model 2180 Spinescope Endoscope… | 1992 |
| * | K011454 | Spine Scope, Model 2180Summary page 2…a skin marking pen, and a scalp.el. The cervical LASE is identical1 to the Clarus-'-MF-odel 2180-Spmnescope (previously cleared for cervical visualization, K01 1454) with a shorter working length and the addition of a fixed laser fiber. The fixed laser fiber is identical to Claru… | 2001 |
| * | K022610 | Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser Fiber, Model 1160Summary page 1…22881 Model 1100 Laser Endoscopic Decompression Kit Clarus Medical, LLC K01I 1454 Model 2180 Spinescope Endoscope Clamus Medical, LLC K0226 10 Model 11 50 Laser Fiber Clarus Medical, LLC Intended Use: The Clarus Model 11I00 Laser En… | 2002 |
What descends from it? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K040919 | Nucleotome Probe Set, Model 21200 | 2004 | 17 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 27, 2021 | Class II | Z-2405-2021 | Packaging process control | The sterile barrier seal may be compromised. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 10.0 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K040919 (Clarus Medical, LLC, 2004) has gone furthest, with 17 descendants of its own.
- 2 other devices also cite its predicate K922881.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 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 1100 Laser Endoscopic Decompression Kit indicated for laser disc decompression in the lumbar and cervical regions of the spine, where the laser is used to remove inner disc material.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040424 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040424: Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model 1120.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040424
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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