# K133132: Optical Biometer AL-Scan

- Pathway: 510(k) (Traditional)
- Applicant: Nidek Co., Ltd.
- Decided: Jun 11, 2014 after 254 days
- Product code: HJO (Biomicroscope, Slit-Lamp, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1850
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K955442 (1996). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082891: Lenstar, Model LS900, Haag-Streit AG (2009) Summary page 1.
- K843696: Ophthalmic a-Scan a-2000  Sonome, Sonomed Technology, Inc. (1985) Summary page 1.
- K020876: Echoscan, Model US-1800, Nidek, Inc. (2002) Summary page 1.
- K030719: Pentacam Scheimpflug Camera, Oculus Optikgerate GmbH (2003) Summary page 1.

## Recalls of this device
- Jul 1, 2016 · Class II · Z-2587-2016: Nidek Inc. received information from our manufacturer NIDEK CO. Japan that the shown axial lengths were much shorter at AL-Scan measurement.

## Indications for use
The OPTICAL BIOMETER AL-Scan is a medical device that optically measures eye components such as: * axial length; * corneal thickness; * anterior chamber depth; * corneal curvature radii; * corneal cylinder axis; * white-to-white distance; and * pupil diameter. Axial length and corneal thickness can also be measured using ultrasound. The OPTICAL BIOMETER AL-Scan also performs calculations to assist physicians in determining the power of the intraocular lens for implantation. Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K133132
Methodology: https://510kreport.com/methodology