# K112154: Femto LDV

- Pathway: 510(k) (Traditional)
- Applicant: Sie Ag,Surgical Instument Engineering
- Decided: Mar 16, 2012 after 233 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- 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.
14 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K131207: Femto LDV (TM) Z-Generation Femtosecond Surgical Laser (2013), 13 descendants of its own
- K141476: Wavelight FS200 Laser System (2014), 8 descendants of its own
- K141852: Ifs Advanced Femtosecond Laser System (2015), 5 descendants of its own
- K173346: LENSAR Laser System - fs 3D (LLS-fs 3D) (2018), 3 descendants of its own
- K181430: LENSAR Laser System - fs 3D (LLS-fs 3D) (2018), 2 descendants of its own

## Recalls of this device
- Apr 16, 2013 · Class II · Z-0811-2014: A defect in the controller board can lead to the condenser to the video monitor becoming too warm. This could potentially cause the video monitor to shut off.

## Indications for use
The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface. The FEMTO LDV Z4 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that does not enclose a volume of the cornea. The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty, penetrating keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect the corneal surface that may enclose a volume of the cornea.

Source page: https://510kreport.com/device/K112154
Methodology: https://510kreport.com/methodology