# P970053: EC-5000 Excimer Laser System

- Pathway: PMA
- Applicant: Nidek Co., Ltd.
- Decided: Dec 17, 1998 after 406 days
- Product code: LZS (Excimer Laser System)
- Device class: 3
- Recalls of this device: 3 (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 1, 2017 · Class II · Z-1494-2017: During treatment planning, the procedure was programmed with an unintended (wrong) correction.
- Mar 24, 2015 · Class II · Z-1710-2015: Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA.
- Aug 6, 2012 · Class II · Z-0223-2015: Contact failure in F1 and F4 fuse holders was detected on the EC-5000 CXIII Excimer Laser Corneal Surgery System that could cause a serious adverse event for the patient.

Source page: https://510kreport.com/device/P970053
Methodology: https://510kreport.com/methodology