# K150323: FEMTO LDV Z8 Surgical Laser

- Pathway: 510(k) (Traditional)
- Applicant: Sie Ag,Surgical Instrument Engineering
- Decided: Oct 23, 2015 after 256 days
- Product code: OOE (Ophthalmic Femtosecond Laser)
- 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: 12 generations back to K913697 (1991). 59 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 62 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.
- K121091: Catalys Precision Laser System, Optimedica Corporation (2012) Summary page 4.

## Most influential descendants
- K213559: FEMTO LDV Z8 Femtosecond Surgical Laser (2022), 1 descendant of its own
- K223566: ELITA™ Femtosecond Laser System, ELITA™ Patient Interface (2023), 0 descendants of its own

## Recalls of this device
- Jan 21, 2018 · Class II · Z-1272-2018: This Correction is being initiated based on a customer complaint received on November 16, 2017 which indicated a complication with a cataract procedure. An investigation completed by the manufacturer 

## Indications for use
The FEMTO LDV™ Z8 Femtosecond Surgical Laser is an ophthalmic surgical laser intended for use in the creation of corneal incisions indicated for use 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 to the corneal surface. In addition, the FEMTO LDV™ Z8 Surgical Laser is intended for use in the creation of capsulotomy, phacofragmentation and the creation of single plane, multi-plane, arc cuts/incisions in the cornea, each of which may be performed either individually or consecutively during the same procedure indicated for use in patients undergoing cataract surgery for removal of the crystalline lens.

Source page: https://510kreport.com/device/K150323
Methodology: https://510kreport.com/methodology