# K122829: Lensar Laser System - FS 3D for Corneal Incisions

- Pathway: 510(k) (Traditional)
- Applicant: Lensar, Inc.
- Decided: Dec 3, 2012 after 77 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- 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). 81 ancestors in all.
5 later devices descend from it; 1 cites 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)
- K120214: TBD, Lensar, Inc. (2012) Summary page 1.
- K101626: Lensx Laser System, Lensx Lasers, Inc. (2010) Summary page 2.

## Most influential descendants
- K123859: TBD (2013), 4 descendants of its own
- 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 single-plane and multi-plane 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/K122829
Methodology: https://510kreport.com/methodology