# K223566: ELITA™ Femtosecond Laser System, ELITA™ Patient Interface

- Pathway: 510(k) (Traditional)
- Applicant: Johnson & Johnson Surgical Vision, Inc.
- Decided: Apr 14, 2023 after 136 days
- Product code: OOE (Ophthalmic Femtosecond Laser)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K913697 (1991). 69 ancestors in all.
No later device cites it as a predicate yet.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213559: FEMTO LDV Z8 Femtosecond Surgical Laser, Sie Ag,Surgical Instrument Engineering (2022) Summary page 4.
- K141852: Ifs Advanced Femtosecond Laser System, Amo Manufacturing USA, LLC (2015) Summary page 4.

## Indications for use
The ELITA™ Femtosecond Laser System is an ophthalmic femtosecond laser indicated in the creation of corneal flap in patients undergoing LASIK surgery or other surgery or treatment requiring initial lamellar resection of the cornea. The ELITA™ Femtosecond Laser System is used in conjunction with a sterile disposable Patient Interface, consisting of a pre-sterilized suction ring assembly and pre-sterilized applanation cone, intended for single-use.

Source page: https://510kreport.com/device/K223566
Methodology: https://510kreport.com/methodology