# P150040: Visumax Femtosecond Laser

- Pathway: PMA
- Applicant: Carl Zeiss Meditec, Inc.
- Decided: Sep 13, 2016 after 319 days
- Product code: OTL (Femtosecond Laser System For Refractive Correction)
- Device class: 3
- 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.
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
- Dec 6, 2018 · Class II · Z-0680-2020: VisuMax devices with software version 2.10.13 and activated SW-Module ReLEx (SMILE) option may experience a software issue. In case of a suction loss during treatment the software allows the user to c

Source page: https://510kreport.com/device/P150040
Methodology: https://510kreport.com/methodology