# K180378: Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module

- Pathway: 510(k) (Traditional)
- Applicant: Optomed OY
- Decided: Apr 5, 2018 after 52 days
- Product code: HKI (Camera, Ophthalmic, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.1120
- 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 K003376 (2001). 5 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132186: Optomed Smartscope M5 / Optomed Smartscope EY4 / Optomed Smartscope ES2, Optomed OY (2013) Summary page 4.

## Most influential descendants
- K221329: Eyer Retinal Camera NM-STD (2023), 2 descendants of its own
- K251353: Eyer 2 (2026), 0 descendants of its own
- K252120: Fundus On Phone Non Mydriatic (FOP NM-10) (2025), 0 descendants of its own
- K243664: Sentinel Camera (2024), 0 descendants of its own

## Indications for use
Optomed Aurora Camera is a medical digital camera that is used with dedicated optics modules intended to capture images and video of the fundus of the eye and surface of the eye. Optomed Aurora Camera with Optomed Aurora Retinal Module is intended to capture digital images and video of the fundus of the human eye. Optomed Aurora Camera with Optomed Aurora Anterior Module is intended to capture digital images and video of the surface of the human eye and surrounding areas.

Source page: https://510kreport.com/device/K180378
Methodology: https://510kreport.com/methodology