# K142837: Heine Sigma 250 & Heine Sigma 250 M2

- Pathway: 510(k) (Abbreviated)
- Applicant: Heine Optotechnik GmbH & Co. KG
- Decided: Jan 29, 2015 after 121 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 K942104 (1994). 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)
- K123316: Heine Omega 500, Heine Optotechnik GmbH & Co. KG (2013) Summary page 5.

## Indications for use
The HEINE SIGMA® 250 (M2) are battery powered indirect ophthalmoscopes for medical professionals, containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, vitreous) and the retina of the eye.

Source page: https://510kreport.com/device/K142837
Methodology: https://510kreport.com/methodology