# K120214: TBD

- Pathway: 510(k) (Traditional)
- Applicant: Lensar, Inc.
- Decided: Jun 8, 2012 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: 12 generations back to K913697 (1991). 74 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090633: Lensar Laser System, Lensar, Inc. (2010) Summary page 1.
- K102727: Lensar Laser System for Anterior Capsulotomy, Lensar, Inc. (2011) Summary page 1.
- K112098: TBD, Lensar, Inc. (2011) Summary page 3.

## Most influential descendants
- K122829: Lensar Laser System - FS 3D for Corneal Incisions (2012), 5 descendants of its own
- 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

## Indications for use
The LensAR Laser System - fs 3D (LLS-fs 3D) is indicated for anterior capsulotomy and laser phaco fragmentation during cataract surgery. The anterior capsulotomy and laser phaco fragmentation procedures may be performed either individually or consecutively during the same surgery.

Source page: https://510kreport.com/device/K120214
Methodology: https://510kreport.com/methodology