Identifiers
- 510(k) Number
- K070534 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 Ocu-Film Tip Cover is a protective accessory designed for manual tonometers, ensuring sterility and contamination control during ophthalmic examinations. It serves as a sterile barrier over the tip of the tonometer probe, preventing cross-contamination between patients and maintaining device hygiene in clinical settings.
Supplied as a single-use item, the Ocu-Film Tip Cover is intended for use with compatible manual tonometers in ophthalmic settings. It adheres to FDA regulatory standards, having received a Special 510(k) clearance under the Ophthalmic advisory committee. The device is classified as Class II and falls under regulation number 886.1930, with no third-party involvement in its review process.
Frequently asked questions
What is the Ocu-Film Tip Cover designed to protect against in clinical settings?
The Ocu-Film Tip Cover is a sterile barrier specifically designed to prevent cross-contamination between patients during ophthalmic examinations. It covers the tip of manual tonometers, ensuring device hygiene by maintaining sterility and reducing the risk of infection transmission in clinical environments.
Is the Ocu-Film Tip Cover reusable, or is it meant for single-use only?
The Ocu-Film Tip Cover is explicitly supplied as a single-use item. This design choice ensures patient safety and sterility, as reuse could compromise the protective barrier and introduce contamination risks.
Which types of manual tonometers is the Ocu-Film Tip Cover compatible with?
The Ocu-Film Tip Cover is intended for use with compatible manual tonometers, as referenced in the product code (HKY) and regulatory classification (886.1930). While exact model compatibility isn’t specified, its design aligns with standard ophthalmic tonometers used in clinical settings.
How was the regulatory approval process for the Ocu-Film Tip Cover conducted?
The Ocu-Film Tip Cover received a Special 510(k) clearance through the FDA’s Ophthalmic Advisory Committee (OP), with no third-party involvement in the review. It was determined to be substantially equivalent to a predicate device, classifying it as a Class II medical device under regulation number 886.1930.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070534 | Class II | Active |
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Manufacturer
- Manufacturer
- Reichert, Inc.
Sources (1)
- FDA 510(k) K070534 24 fields · synced Sep 19, 2026