# K123859: TBD

- Pathway: 510(k) (Traditional)
- Applicant: Lensar, Inc.
- Decided: Mar 27, 2013 after 103 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). 82 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122829: Lensar Laser System - FS 3D for Corneal Incisions, Lensar, Inc. (2012) Summary page 1.
- K120214: TBD, Lensar, Inc. (2012) Summary page 1.
- K101626: Lensx Laser System, Lensx Lasers, Inc. (2010) Summary page 1.

## Most influential descendants
- K143010: LENSAR Laser System - fs 3D (2015), 3 descendants of its own
- K152453: LENSAR Laser System - fs 3D (LLS-fs 3D) (2015), 2 descendants of its own
- K170576: LENSAR Laser System - fs 3D (LLS-fs 3D) (2017), 1 descendant of its own
- K171337: LENSAR Laser System – fs 3D (LLS-fs 3D) (2017), 0 descendants of its own

## Indications for use
The LENSAR Laser System - fs 3D (LLS-fs 3D) is intended for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, laser phacofragmentation, and the creation of full and partial thickness single-plane and multi-plane arc 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/K123859
Methodology: https://510kreport.com/methodology