# P930016: Visx Excimer Laser System Models B and C

- Pathway: PMA
- Applicant: Amo Manufacturing USA, LLC
- Decided: Mar 27, 1996 after 1,016 days
- Product code: LZS (Excimer Laser System)
- Device class: 3
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Oct 21, 2021 · Class II · Z-0443-2022: Aberrometer and precision laser systems are affected by a remote code execution vulnerability existing when the Microsoft Windows Print Spooler service is enabled, and improperly performs privileged f
- Dec 13, 2007 · Not classified · Z-1139-2008: Firm received two complaints (including one injury complaint) associated with the movement of the VISX chair while in the patient loading ("fully swung out" unlocked) position under an IntraLase FS la

Source page: https://510kreport.com/device/P930016
Methodology: https://510kreport.com/methodology