# K173371: VisuMax Femtosecond Laser

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, Inc.
- Decided: Apr 13, 2018 after 168 days
- Product code: HNO (Keratome, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 886.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K913697 (1991). 70 ancestors in all.
No later device cites it as a predicate yet.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100253: Visumax  Laser Keratome, Carl Zeiss Meditec, AG (2010) Summary page 4.
- K141476: Wavelight FS200 Laser System, Alcon Research, Ltd. Dba Alcon Laboratories, Inc. (2014) Summary page 4.
- K141852: Ifs Advanced Femtosecond Laser System, Amo Manufacturing USA, LLC (2015) Summary page 4.

## Indications for use
The VisuMax Femtosecond Laser is cleared for the following indications for use: • In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea; • In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea; • In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty; • In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting; • In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments.

Source page: https://510kreport.com/device/K173371
Methodology: https://510kreport.com/methodology