# K090633: Lensar Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Lensar, Inc.
- Decided: May 13, 2010 after 430 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: 9 generations back to K913697 (1991). 49 ancestors in all.
18 later devices descend from it; 4 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K892058: ISL QC 2000, Intelligent Surgical Lasers, Inc. (1989) Summary page 2.
- K001498: The Fugo Blade, Medisurg, Ltd. (2000) Summary page 2.
- K082947: Lensx 550 Laser System, Lensx Lasers, Inc. (2009). Cleared while this submission was under review Summary page 2.

## Most influential descendants
- K102727: Lensar Laser System for Anterior Capsulotomy (2011), 12 descendants of its own
- K110427: Femtec Laser System for Capsulotomy (2011), 8 descendants of its own
- K120426: Victus Laser Platform (2012), 7 descendants of its own
- K112098: TBD (2011), 7 descendants of its own
- K122386: Victus Femtosecond Laser Platform (2013), 6 descendants of its own

## Indications for use
The LensAR Laser System is indicated for anterior capsulotomy in cataract surgery.

Source page: https://510kreport.com/device/K090633
Methodology: https://510kreport.com/methodology