# K052599: 66 Vision Tech Ophthalmoscope, Models YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25A

- Pathway: 510(k) (Traditional)
- Applicant: Suzhou 66 Vision Tech Co., Ltd.
- Decided: Nov 7, 2006 after 412 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 66 Vision Tech Ophthalmoscopes (Indirect and Direct) are intended to examine the cornea, aqueous, lens and vitreous and the retina of the eye.

Source page: https://510kreport.com/device/K052599
Methodology: https://510kreport.com/methodology