# K032769: Eyesopen Tonometer

- Pathway: 510(k) (Traditional)
- Applicant: Eye-Deas, LLC
- Decided: Sep 23, 2003 after 15 days
- Product code: HKY (Tonometer, Manual)
- Device class: 2
- Regulation: 21 CFR 886.1930
- 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. The FDA summary names its predicate without a number.
- (no number) Perkins tonometer: named in the summary without a submission number
- (no number) Tono-Pen 3 tonometer: named in the summary without a submission number

## Indications for use
The EYE-deas EyesOPen tonometer is used to measure the intraocular pressure (IOP) during routine eye examinations or when an increased IOP is suspected. This device is intended for use by Ophthalmologists. Optometrists. and other trained medical professionals.

Source page: https://510kreport.com/device/K032769
Methodology: https://510kreport.com/methodology