# K082891: Lenstar, Model LS900

- Pathway: 510(k) (Traditional)
- Applicant: Haag-Streit AG
- Decided: Oct 20, 2009 after 385 days
- Product code: HJO (Biomicroscope, Slit-Lamp, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1850
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K955442 (1996). 18 ancestors in all.
14 later devices descend from it; 5 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993357: Iolmaster, Carl Zeiss, Inc. (2000) Summary page 2.
- K030393: Optical Low Coherence Reflectometry (Olcr) Pachymeter, Haag-Streit Holding AG (2003) Summary page 2.
- K032956: Accusonic a-Scan  Model, 24-4000, Accutome, Inc. (2003) Summary page 2.
- K944616: Keratron Corneal Topographer, Alliance Medical Marketinig (1994) Summary page 2.

## Most influential descendants
- K101182: Iolmaster 500 (2010), 10 descendants of its own
- K122418: Iolmaster 500 (2013), 9 descendants of its own
- K143275: IOLMaster700 (2015), 4 descendants of its own
- K170171: IOLMaster 700 (2017), 3 descendants of its own
- K152311: Pentacam AXL (2016), 3 descendants of its own

## Recalls of this device
- Apr 15, 2021 · Class II · Z-1560-2021: Examination data and patient name may be mixed up when printing or generating a pdf with the interface at Pacific Coast and Laser Institute (PCLI).
- Jun 20, 2011 · Not classified · Z-2964-2011: A patient record may be linked to an incorrect/inconsistent set of calculation results under specific circumstances when using EyeSuite Software version i2.000.
- May 19, 2010 · Not classified · Z-1897-2010: During the creation of the Lenstar LS 900 software, the ability to perform a manual adjustment of the retinal thickness measurement was not disabled for products targeted for US distribution. The curr

## Indications for use
The LENSTAR LS 900 is a non-invasive, non-contact OLCR (Optical Low Coherence Reflectometry) Biometer used for obtaining ocular measurements and performing calculations to assist in the determination of the appropriate power and type of IOL (intraocular lens) for implantation after removal of the natural crystalline lens following cataract removal. The LENSTAR LS 900 measures: Axial eye length Corneal thickness Anterior chamber depth Aqueous depth Lens thickness Radii of curvature of flat and steep meridian Axis of the flat meridian White to white distance Pupil diameter

Source page: https://510kreport.com/device/K082891
Methodology: https://510kreport.com/methodology