# K131961: Heine Beta 200(R) Ophthalmoscope

- Pathway: 510(k) (Abbreviated)
- Applicant: Heine Optotechnik GmbH & Co. KG
- Decided: Dec 4, 2013 after 160 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 2.

## Indications for use
This instrument is designed for examination of the eye. BETA handles are designed exclusively for use with medical examination instruments With bulb illumination.

Source page: https://510kreport.com/device/K131961
Methodology: https://510kreport.com/methodology