# K173346: LENSAR Laser System - fs 3D (LLS-fs 3D)

- Pathway: 510(k) (Traditional)
- Applicant: Lensar, Inc.
- Decided: Mar 2, 2018 after 128 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: 13 generations back to K913697 (1991). 67 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141476: Wavelight FS200 Laser System, Alcon Research, Ltd. Dba Alcon Laboratories, Inc. (2014) Summary page 4.

## Most influential descendants
- K181430: LENSAR Laser System - fs 3D (LLS-fs 3D) (2018), 2 descendants of its own
- K182795: LENSAR Laser System - fs 3D (LLS-fs 3D) (2018), 1 descendant of its own
- K220259: ALLY Adaptive Cataract Treatment System (2022), 0 descendants of its own

## Indications for use
The LENSAR Laser System — fs 3D (LLS-fs 3D) with Streamline™ is an ophthalmic surgical laser indicated for use: * in the creation of an anterior capsulotomy; * in patients undergoing surgery requiring laser-assisted fragmentation of the cataractous lens; * in the creation of full and partial thickness single-plane and multi-plane arc cuts/incisions in the cornea; * in patients undergoing ophthalmic surgery or other treatments requiring pocket cuts/incisions in the cornea; and * in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea.

Source page: https://510kreport.com/device/K173346
Methodology: https://510kreport.com/methodology