# K093495: Otoscope and Ophthalmoscope Diagnostic Instrument Kits

- Pathway: 510(k) (Traditional)
- Applicant: American Diagnostic Corp.
- Decided: Nov 19, 2010 after 374 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The ophthalmoscope kits described in this submission include a battery handle and attachments which serve the intended use below. The ophthalmoscope is a hand held, battery-powered device containing illumination and viewing optics intended to examine the media (cornea, aqueous, lens, and vitreous) and the retina of the eye. It is intended to be used by a trained healthcare professional.

Source page: https://510kreport.com/device/K093495
Methodology: https://510kreport.com/methodology