# K052935: Heidelberg Engineering Slitlamp-Oct (SL-Oct)

- Pathway: 510(k) (Traditional)
- Applicant: Heidelberg Engineering
- Decided: Jan 13, 2006 after 86 days
- Product code: MXK (Device, Analysis, Anterior Segment)
- Device class: 2
- Regulation: 21 CFR 886.1850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K955442 (1996). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030393: Optical Low Coherence Reflectometry (Olcr) Pachymeter, Haag-Streit Holding AG (2003) Summary page 2.

## Indications for use
The SL OCT is an add on for a slit lamp biomicroscope and is intended for use in eye examination of the anterior eye segment, from the corneal epithelium to the posterior capsule. It is used for diagnostic purposes.

Source page: https://510kreport.com/device/K052935
Methodology: https://510kreport.com/methodology