# K040424: Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model 1120

- Pathway: 510(k) (Traditional)
- Applicant: Clarus Medical, LLC
- Decided: May 11, 2004 after 83 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K922881 (1992). 7 ancestors in all.
18 later devices descend from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922881: Clarus Models 1100, 1101, 1102, 1103 Laser Disc, Clarus Medical Systems, Inc. (1992) Summary page 1.
- K011454: Spine Scope, Model 2180, Clarus Medical, LLC (2001) Summary page 2.
- K022610: Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser Fiber, Model 1160, Clarus Medical, LLC (2002) Summary page 1.

## Most influential descendants
- K040919: Nucleotome Probe Set, Model 21200 (2004), 17 descendants of its own
- K062038: X-Sten Mild Tool Kit, Model MTK-0001 (2006), 14 descendants of its own
- K093062: Vertos Medical Mild Device Kit (2010), 13 descendants of its own
- K180876: DTRAX Spinal System (2018), 7 descendants of its own
- K190201: CORUS Spinal System (2019), 6 descendants of its own

## Recalls of this device
- Jul 27, 2021 · Class II · Z-2405-2021: The sterile barrier seal may be compromised.

## Indications for use
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.

Source page: https://510kreport.com/device/K040424
Methodology: https://510kreport.com/methodology