# K113129: Spectralis Anterior Segment Module (Spectralis Asm)

- Pathway: 510(k) (Traditional)
- Applicant: Heidelberg Engineering GmbH
- Decided: Nov 8, 2011 after 15 days
- Product code: OBO (Tomography, Optical Coherence)
- Device class: 2
- Regulation: 21 CFR 886.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K941234 (1995). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071250: CA, Model: Cam, Optovue, Inc. (2007) Summary page 1.
- K101223: Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FA, Heidelberg Engineering (2010) Summary page 1.

## Indications for use
The Spectralis Anterior Segment Module is an accessory to the Spectralis HRA+OCT, and is indicated for imaging the anterior segment of the eye.

Source page: https://510kreport.com/device/K113129
Methodology: https://510kreport.com/methodology