# K142486: Heine Beta 200, Heine Beta 200 S, Heine K 180

- Pathway: 510(k) (Abbreviated)
- Applicant: Heine Optotechnik GmbH & Co. KG
- Decided: May 18, 2015 after 256 days
- Product code: HLJ (Ophthalmoscope, Battery-Powered)
- 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: 3 generations back to K925757 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123587: Heine Mini 3000 Led Ophthalmoscope, Heine Optotechnik GmbH & Co. KG (2013) Summary page 5.

## Indications for use
HEINE Direct ophthalmoscopes are intended for examination of the media (cornea, aqueous humour, lens, vitreous humour) and retina of the eye.

Source page: https://510kreport.com/device/K142486
Methodology: https://510kreport.com/methodology