Identifiers
- 510(k) Number
- K011199 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 ProView Eye Pressure Monitor is a manual tonometer, a device used to measure intraocular pressure (IOP) in the eye. It employs a phosphene-based method, where pressure is applied to the closed eyelid, and the resulting pressure is read from a calibrated scale on the device. This measurement aids in diagnosing and monitoring glaucoma and other ocular conditions by assessing fluid pressure within the eye.
The device is supplied as a reusable, non-sterile instrument intended for clinical use in ophthalmic settings. It is packaged in a black snap-hinged metal case with a black faux leather zipped outer case measuring 261 mm × 200 mm × 35 mm, along with accessories such as lens cleaning tissues, a Fresnel magnifier, and instructional materials. The ProView Eye Pressure Monitor holds an FDA 510(k) clearance (K011199) under the classification of a Class II medical device (regulation number 886.1930), with an advisory committee designation for ophthalmic applications.
Frequently asked questions
How is the ProView Eye Pressure Monitor different from other tonometers in terms of how it measures intraocular pressure?
The ProView Eye Pressure Monitor uses a phosphene-based method to measure intraocular pressure (IOP), which involves applying pressure to the closed eyelid. Unlike some other tonometers that require direct contact with the cornea, this device relies on the patient’s perception of pressure through the eyelid, making it a non-contact alternative for certain measurements. This approach aids in diagnosing and monitoring conditions like glaucoma by assessing fluid pressure within the eye without needing corneal applanation.
Is the ProView Eye Pressure Monitor intended for single-use or can it be reused in a clinical setting?
The ProView Eye Pressure Monitor is explicitly designed as a reusable instrument for clinical use in ophthalmic settings. It is supplied in a durable metal case with accessories like lens cleaning tissues, which suggests it is meant to be cleaned and reused between patients. However, proper sterilization protocols must be followed to ensure patient safety and device integrity.
What accessories are included with the ProView Eye Pressure Monitor, and how do they contribute to its use?
The device comes packaged in a black snap-hinged metal case with a faux leather outer case. Included accessories are lens cleaning tissues, a Fresnel magnifier, and instructional materials. The cleaning tissues help maintain the device’s accuracy by keeping the measurement surfaces free of debris, while the magnifier aids in reading the calibrated scale more precisely. The instructional materials ensure proper handling and operation.
How is the ProView Eye Pressure Monitor stored, and what are the dimensions of its packaging?
The ProView Eye Pressure Monitor is stored in a black snap-hinged metal case with a protective black faux leather zipped outer case. The outer case measures 261 mm × 200 mm × 35 mm, providing a compact yet sturdy enclosure for transport and storage. This design helps protect the device and its accessories from damage while maintaining accessibility for clinical use.
What regulatory pathway was followed for the FDA clearance of the ProView Eye Pressure Monitor, and what classification does it hold?
The ProView Eye Pressure Monitor received FDA 510(k) clearance (K011199) under the classification of a Class II medical device, regulated under 21 CFR 886.1930. The clearance was granted through a traditional 510(k) review process, with a determination of substantial equivalence to a predicate device. The device is also designated under the Ophthalmic Advisory Committee (OP), reflecting its intended use in ophthalmic applications.
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: Archive - Proview Eye Pressure Monitor - Optometry Museum & Archive, The Proview phosphene tonometer fails to measure ocular pressure ..., Bausch & Lomb Proview Eye Pressure Monitor with case book in ... - eBay
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K011199 | Class II | Active |
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Manufacturer
- Manufacturer
- Bausch & Lomb, Inc.
Sources (1)
- FDA 510(k) K011199 24 fields · synced Oct 6, 2026