# K132917: Ocular Force Gauge

- Pathway: 510(k) (Traditional)
- Applicant: Ocular Therapeutix, Inc.
- Decided: Dec 20, 2013 after 94 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) Ophthalmodynamometer: named in the summary without a submission number

## Indications for use
The Ocular Force Gauge is indicated for applying measured force to the surface of the eye.

Source page: https://510kreport.com/device/K132917
Methodology: https://510kreport.com/methodology