# P970043: Ladarvision Excimer Laser System

- Pathway: PMA
- Applicant: Alcon Laboratories
- Decided: Nov 2, 1998 after 423 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
- Feb 21, 2007 · Not classified · Z-0854-2007: Observed 'central islands' in patients following custom myopia laser procedures using the LADAR6000 Excimer Laser. (On May 11, 2007, Alcon notified consignees that the device software programs for Cus
- Aug 1, 2005 · Not classified · Z-1147-06: Alcon has identified a software error associated with the use of the Measuring Mode (ruler tool) on the LADARVision4000 Excimer Laser Systems. Use of this feature after alignment of the horizontal ref

Source page: https://510kreport.com/device/P970043
Methodology: https://510kreport.com/methodology