# K082947: Lensx 550 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Lensx Lasers, Inc.
- Decided: Aug 14, 2009 after 316 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: 8 generations back to K913697 (1991). 48 ancestors in all.
51 later devices descend from it; 7 cite it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001498: The Fugo Blade, Medisurg, Ltd. (2000) Summary page 2.
- K040005: Profile 2000/3000 Laser System, Sciton, Inc (2004) Summary page 2.
- K052806: Burane, Wavelight Laser Technologie AG (2005) Summary page 2.
- K021548: Fotona Dualis ND:Yag/ER:Yag Laser System, Fotona D.D. (2002) Summary page 2.
- K033354: Femtec Laser Microkeratome, 20/10 Perfect Vision Optische Gerate GmbH (2004) Summary page 2.
- K993153: Intralase 600C Laser Keratome, Intra Lase Corp. (1999) Summary page 2.
- K001211: Modification to Intralase 600C Laser Keratome, Intra Lase Corp. (2000) Summary page 2.
- K002890: Intralase 600C Laser Keratome, Intra Lase Corp. (2001) Summary page 2.
- K013941: Pulsion FS Laser Keratome, Intra Lase Corp. (2002) Summary page 2.
- K031960: Intralase FS Laser, Intra Lase Corp. (2003) Summary page 2.
- K041893: Intralase FS Laser, Intra Lase Corp. (2005) Summary page 2.
- K060372: Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3, Intra Lase Corp. (2006) Summary page 2.
- K063682: Intralase Fusion Laser, Intra Lase Corp. (2007) Summary page 2.
- K073404: Ifs Laser System, Intra Lase Corp. (2008) Summary page 2.

## Most influential descendants
- K094052: Lensx 550 Laser System. Model 550 (2010), 47 descendants of its own
- K092647: Lensx 550 Laser System (2009), 31 descendants of its own
- K101626: Lensx Laser System (2010), 30 descendants of its own
- K113151: Ifs Laser System (2012), 19 descendants of its own
- K090633: Lensar Laser System (2010), 18 descendants of its own

## Indications for use
The LenSx 550 Laser System is indicated for anterior capsulotomy during cataract surgery.

Source page: https://510kreport.com/device/K082947
Methodology: https://510kreport.com/methodology