# K101626: Lensx Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Lensx Lasers, Inc.
- Decided: Oct 18, 2010 after 131 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: 10 generations back to K913697 (1991). 60 ancestors in all.
30 later devices descend from it; 7 cite it directly.
0 of 91 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.
- K094052: Lensx 550 Laser System. Model 550, Lensx Lasers, Inc. (2010). Our OCR of the scanned summary read K090452, FDA’s number for Neoss Implant System 03.25 (Neoss, Ltd.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “LenSx 550 Laser System”.
- K092647: Lensx 550 Laser System, Lensx Lasers, Inc. (2009) Summary page 1.
- K041893: Intralase FS Laser, Intra Lase Corp. (2005) Summary page 1.
- K822112: Ophthalmic Knife, Sharpoint, Inc. (1982) Summary page 1.
- K853598: Ophthalmic Knife W/Removale Depth Guide, Myocure, Inc. (1985) Summary page 1.
- K863725: Cataract Diamond Knife, Medical Technology Development Corp. (1986) Summary page 1.

## Most influential descendants
- 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
- K122386: Victus Femtosecond Laser Platform (2013), 6 descendants of its own

## Indications for use
The LenSx Laser is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of,which may be performed either individually or consecutively during the same procedure. The LenSx Laser is indicated for use in patients undergoing penetrating keratoplasty for full thickness corneal replacement and in patients undergoing lamellar keratoplasty for partial thickness comeal replacement. The intended use in penetrating and lamellar keratoplasty includes the creation of single plane and multi-plane arc and circular cuts/incisions in the cornea.

Source page: https://510kreport.com/device/K101626
Methodology: https://510kreport.com/methodology