# K112098: TBD

- Pathway: 510(k) (Traditional)
- Applicant: Lensar, Inc.
- Decided: Oct 19, 2011 after 89 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: 11 generations back to K913697 (1991). 73 ancestors in all.
7 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)
- K102727: Lensar Laser System for Anterior Capsulotomy, Lensar, Inc. (2011) Summary page 1.
- K090633: Lensar Laser System, Lensar, Inc. (2010) Summary page 1.
- K082947: Lensx 550 Laser System, Lensx Lasers, Inc. (2009) Summary page 2.

## Cited in the summary but kept off the family tree
- K094052: Lensx 550 Laser System. Model 550, Lensx Lasers, Inc. (2010). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K089475: LenSx 550 Laser System Model 550. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K120214: TBD (2012), 6 descendants of its own
- 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

## Indications for use
The LensAR-fs Laser System 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/K112098
Methodology: https://510kreport.com/methodology