# K182795: LENSAR Laser System - fs 3D (LLS-fs 3D)

- Pathway: 510(k) (Traditional)
- Applicant: Lensar, Inc.
- Decided: Dec 21, 2018 after 81 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: 15 generations back to K913697 (1991). 69 ancestors in all.
1 later device descends 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)
- K181430: LENSAR Laser System - fs 3D (LLS-fs 3D), Lensar, Inc. (2018) Summary page 4.
- K141476: Wavelight FS200 Laser System, Alcon Research, Ltd. Dba Alcon Laboratories, Inc. (2014) Summary page 4.

## Most influential descendants
- 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; • in the creation of a corneal flap in patients undergoing treatment requiring initial lamellar resection of the cornea; • in patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments; and • in the creation of partial thickness single-plane radial cuts/incisions in the cornea

Source page: https://510kreport.com/device/K182795
Methodology: https://510kreport.com/methodology