# K123316: Heine Omega 500

- Pathway: 510(k) (Abbreviated)
- Applicant: Heine Optotechnik GmbH & Co. KG
- Decided: Feb 26, 2013 after 124 days
- Product code: HLI (Ophthalmoscope, Ac-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: 2 generations back to K942104 (1994). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060822: Vantage Indirect Ophthalmoscope, Keeler Instruments, Inc. (2006) Summary page 2.
- K942712: Neitz Halogen Binocular Indirect Ophthalmoscope IO-a, Neitz Instruments Company, Ltd. (1994) Summary page 2.
- K930023: Model #12000 Binocular Inderect Ophthalmoscope, Welch Allyn, Inc. (1993) Summary page 2.

## Most influential descendants
- K142837: Heine Sigma 250 & Heine Sigma 250 M2 (2015), 0 descendants of its own
- K141638: Propper Insight Binocular Indirect Ophthalmosope (2014), 0 descendants of its own

## Indications for use
The indirect ophthalmoscope HEINE OMEGA® 500 is an AC-powered or battery powered device 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/K123316
Methodology: https://510kreport.com/methodology