Identifiers
- 510(k) Number
- K132917 FDA 510(k)
- FDA Product Code
- HKY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.1930 FDA 510(k)
- Regulation Number
- 886.1930 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ocular Force Gauge is a Manual Tonometer, a precision spring-scale instrument designed to apply and measure controlled force to the ocular surface. It functions as a reusable, non-sterile device for assessing intraocular pressure or evaluating mechanical properties of the eye, particularly in research or clinical settings requiring calibrated force application.
This hand-held device features a smooth, foot-shaped attachment resembling an ophthalmodynamometer, enabling precise force delivery. Supplied as a reusable instrument, it is intended for use in controlled environments such as ophthalmic laboratories or clinical trials. The device holds an FDA 510(k) clearance under the classification of Class II medical devices, adhering to regulatory standards for ophthalmic instrumentation.
Frequently asked questions
What is the primary purpose of the Ocular Force Gauge in clinical or research settings?
The Ocular Force Gauge is designed to apply and measure controlled force to the ocular surface, functioning as a manual tonometer. It is specifically used to assess intraocular pressure or evaluate the mechanical properties of the eye, particularly in research or clinical trials where precise force calibration is required. Its foot-shaped attachment allows for accurate and consistent force delivery, making it suitable for specialized ophthalmic applications.
Is the Ocular Force Gauge intended for single-use or can it be reused?
The Ocular Force Gauge is explicitly described as a reusable device. It is not sterile and is intended for use in controlled environments like ophthalmic laboratories or clinical trials, where it can be cleaned and reused for multiple measurements. However, proper sterilization or cleaning protocols must be followed to maintain accuracy and prevent contamination.
How is the Ocular Force Gauge regulated, and what does its FDA clearance status indicate?
The Ocular Force Gauge holds an FDA 510(k) clearance under the classification of Class II medical devices. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device, meaning it meets regulatory standards for safety and effectiveness as an ophthalmic instrument. The clearance was granted through a traditional review process by the FDA’s Ophthalmic Advisory Committee.
What types of environments or settings is the Ocular Force Gauge intended for?
The device is supplied as a reusable instrument and is explicitly intended for use in controlled environments such as ophthalmic laboratories or clinical trials. Its design and regulatory classification suggest it is not meant for routine patient care in standard clinical settings but rather for specialized applications where calibrated force measurement is critical, such as research or precision diagnostics.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Products | Innovative Eye Care Solutions by Ocular Therapeutix, PDF 6 32j-91 7 Ocular Force Gauge AND EFFECTIIV, Ocular Therapeutix, Inc._December 31, 2025
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K132917 | Class II | Active |
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Manufacturer
- Manufacturer
- Ocular Therapeutix, Inc.
Sources (1)
- FDA 510(k) K132917 24 fields · synced Sep 19, 2026