# K094052: Lensx 550 Laser System. Model 550

- Pathway: 510(k) (Traditional)
- Applicant: Lensx Lasers, Inc.
- Decided: Apr 23, 2010 after 113 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). 54 ancestors in all.
47 later devices descend from it; 4 cite it directly.
0 of 102 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 1.
- K993154: Laser Photolysis System, Pharo Ophthalmic Surgery System, A.R.C. Laser Corp. (2000) Summary page 1.
- K952213: Alcon Series 20000 Legacy Phacoemulsifier, Alcon Laboratories (1995) Summary page 1.

## Most influential descendants
- K101626: Lensx Laser System (2010), 30 descendants of its own
- K113151: Ifs Laser System (2012), 19 descendants of its own
- K113479: Optimedica Catalys Precision Laser System (2011), 13 descendants of its own
- K120732: Lenssx Laser System (2012), 12 descendants of its own
- K121091: Catalys Precision Laser System (2012), 12 descendants of its own

## Indications for use
The LenSx 550 Laser System is indicated for anterior capsulotomy and laser phacofragmentation during cataract surgery. The anterior capsulotomy and phacofragmentation procedures may be performed either individually or consecutively during the same surgery.

Source page: https://510kreport.com/device/K094052
Methodology: https://510kreport.com/methodology