# K220263: Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers

- Pathway: 510(k) (Traditional)
- Applicant: Vortex Surgical, Inc.
- Decided: Nov 3, 2022 after 276 days
- Product code: HQB (Photocoagulator And Accessories)
- Device class: 2
- Regulation: 21 CFR 886.4690
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K870942 (1987). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191846: MAXReach Laser Probe, Vortex Surgical, Inc. (2019) Summary page 4.

## Recalls of this device
- Dec 16, 2025 · Class II · Z-1246-2026: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to 
- Dec 16, 2025 · Class II · Z-1245-2026: There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to 
- Nov 19, 2025 · Class II · Z-1004-2026: Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.

## Indications for use
Vortex Surgical Laser Probes and Illuminated Laser Probes are indicated for use in laser endophotocoagulation procedures in the posterior segment of the eye during vitreoretinal surgery at 500nm to 1100nm. Vortex Surgical Illuminated Laser Probes, Endoilluminator, and Chandelier are indicated for illumination during vitreoretinal surgery with visible light.

Source page: https://510kreport.com/device/K220263
Methodology: https://510kreport.com/methodology