# K141852: Ifs Advanced Femtosecond Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Amo Manufacturing USA, LLC
- Decided: Jan 6, 2015 after 181 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K913697 (1991). 64 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131207: Femto LDV (TM) Z-Generation Femtosecond Surgical Laser, Surgical Instrument Engineering AG (2013) Summary page 4.
- K113151: Ifs Laser System, Abbott Medical Optics, Inc. (2012) Summary page 4.

## Most influential descendants
- K173660: LenSx Laser System (2018), 2 descendants of its own
- K243896: LenSx Laser System (8065998162) (2025), 1 descendant of its own
- K252682: LenSx Laser System (8065000944) (2025), 0 descendants of its own
- K223566: ELITA™ Femtosecond Laser System, ELITA™ Patient Interface (2023), 0 descendants of its own
- K173371: VisuMax Femtosecond Laser (2018), 0 descendants of its own

## Indications for use
In patients undergoing 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 to create tunnels for placement of corneal ring segments In patients undergoing ophthalmic surgery or other treatment requiring arcuate cuts/incisions in the cornea, penetrating and/or intrastromal In lamellar IEK and corneal harvesting In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea In the creation of a lamellar cut/resection of the cornea for lamellar IEK and for the creation of a penetrating cut/incision for penetrating IEK In patients undergoing ophthalmic surgery or other treatment requiring the creation of corneal channel for placement/insertion of a corneal inlay device

Source page: https://510kreport.com/device/K141852
Methodology: https://510kreport.com/methodology