# K061278: Optyse Ophthalmoscope

- Pathway: 510(k) (Abbreviated)
- Applicant: Ophthalmos, Ltd.
- Decided: May 16, 2006 after 8 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: 1 generation back to K925756 (1993). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925756: UNI II, Rudolf Riester GmbH & Co. KG (1993) Summary page 1.

## Indications for use
The Optyse M Lens Free Ophthalmoscope is a direct ophthalmoscope intended to be used to examine the fundus or the inside of the back of the eye

Source page: https://510kreport.com/device/K061278
Methodology: https://510kreport.com/methodology