# K922881: Clarus Models 1100, 1101, 1102, 1103 Laser Disc

- Pathway: 510(k) (Traditional)
- Applicant: Clarus Medical Systems, Inc.
- Decided: Nov 16, 1992 after 153 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
No predicates in its family tree.
21 later devices descend from it; 3 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022610: Clarus Straight Firing Laser Fiber, Model 1150, Clarus Side Firing Laser Fiber, Model 1160 (2002), 19 descendants of its own
- K040424: Laser Endoscopic Decompression Kit, Model 1100, and Percutaneous Discectomy Kit, Model 1120 (2004), 18 descendants of its own
- 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

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

Source page: https://510kreport.com/device/K922881
Methodology: https://510kreport.com/methodology