# K050271: Kowa Genesis-D Hand-Held Retinal Camera

- Pathway: 510(k) (Traditional)
- Applicant: Kowa Co., Ltd.
- Decided: Nov 3, 2005 after 272 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Kowa Genesis: named in the summary without a submission number
- (no number) Nidek Handy NM-100: named in the summary without a submission number

## Most influential descendants
- K102412: Vista Digital Opthalmoscope (2011), 2 descendants of its own
- K121405: Panoptic (2012), 1 descendant of its own
- K091098: Kowagenesis-DF (2009), 1 descendant of its own
- K223381: iExaminer System with Panoptic Plus (2023), 0 descendants of its own
- K201325: Optomed Smartscope M5 with Optomed Smartscope FA (2020), 0 descendants of its own

## Indications for use
The Kowa hand-held retinal camera, KOWA GENESIS-D is a device intended to capture and save fundus images with mydriatic.

Source page: https://510kreport.com/device/K050271
Methodology: https://510kreport.com/methodology