# K092647: Lensx 550 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Lensx Lasers, Inc.
- Decided: Dec 11, 2009 after 106 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). 50 ancestors in all.
31 later devices descend from it; 1 cites it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082947: Lensx 550 Laser System, Lensx Lasers, Inc. (2009) Summary page 2.
- K041893: Intralase FS Laser, Intra Lase Corp. (2005) Summary page 2.
- K981063: Automated Corneal Trephine, Laser Center Dev. Corp. (1998) Summary page 2.
- K013151: Asmotom Automated Trephine System, Bkg Opthalmics USA, Inc. (2001) Summary page 2.
- K864520: Barron Rotary Blade Trephine Using Hessburg-Barron, Precision Instruments, Inc. (1987) Summary page 2.
- K861825: Corneal Transplant Trephine Disposable Blade, Storz Instrument Co. (1986) Summary page 2.

## Most influential descendants
- K101626: Lensx Laser System (2010), 30 descendants of its own
- K113151: Ifs Laser System (2012), 19 descendants of its own
- K120732: Lenssx Laser System (2012), 12 descendants of its own
- K141476: Wavelight FS200 Laser System (2014), 8 descendants of its own
- K120426: Victus Laser Platform (2012), 7 descendants of its own

## Indications for use
The LenSx 550 Laser System is indicated for use in the creation of a partial thickness cut/incision for lainellar keratoplasty and in the creation of a full-thickness cut/incision for penetrating keratoplasty.

Source page: https://510kreport.com/device/K092647
Methodology: https://510kreport.com/methodology