# K131207: Femto LDV (TM) Z-Generation Femtosecond Surgical Laser

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Instrument Engineering AG
- Decided: Oct 9, 2013 after 163 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
Longest line of descent: 1 generation back to K112154 (2012). 1 ancestor in all.
13 later devices descend from it; 3 cite 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)
- K112154: Femto LDV, Sie Ag,Surgical Instument Engineering (2012) Summary page 1.

## Most influential descendants
- 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
- K173660: LenSx Laser System (2018), 2 descendants of its own

## Recalls of this device
- Dec 18, 2014 · Class II · Z-0988-2015: The devices were not shipped with the Starter Kits.

## Indications for use
The FEMVTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for the use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, packet 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 to the corneal surface. In addition, the FEMVTO LDV Z6 Surgical Laser is intended far use in patients undergoing cataract surgery for the creation of single-plane, multi-plane, partial thickness and full thickness cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure.

Source page: https://510kreport.com/device/K131207
Methodology: https://510kreport.com/methodology