# K012803: AL-2000 Combined Biometer and Pachymeter

- Pathway: 510(k) (Traditional)
- Applicant: Tomey Corp.
- Decided: Apr 8, 2002 after 230 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K910956 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910956: Compuscan LT Biometric Ruler and Iol Calculator, Storz Instrument Co. (1991) Summary page 1.
- K913067: DGH-4000 a-Scan/Pachymeter, Dgh Technology, Inc. (1992) Summary page 1.

## Indications for use
The AL-2000 is indicated for: The axial length measurement of the eye by ultrasonic means; The implanted IOL power calculation, using the axial length measurement; Measurement of the corneal thickness before, during and after corneal and refractive surgery; for corneal disease assessment; and for contact lens fitting.

Source page: https://510kreport.com/device/K012803
Methodology: https://510kreport.com/methodology