Identifiers
- 510(k) Number
- K971186 FDA 510(k)
- FDA Product Code
- HQC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.4670 FDA 510(k)
- Regulation Number
- 886.4670 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The AMO Diplomax/Opsys Console is a phacofragmentation device designed for cataract removal procedures. It provides surgical capabilities for anterior segment and cataract surgeons.
This device is manufactured by Allergan, Inc. and received FDA 510(k) clearance with the K971186 number. It is a Class II device registered under product code HQC and regulation number 886.4670.
Frequently asked questions
What is the AMO Diplomax/Opsys Console used for?
The AMO Diplomax/Opsys Console is a phacofragmentation device specifically designed for cataract removal procedures. It provides surgical capabilities for anterior segment and cataract surgeons to perform these operations effectively.
What is the regulatory status of the AMO Diplomax/Opsys Console?
The AMO Diplomax/Opsys Console has received FDA 510(k) clearance with the K971186 number. It is classified as a Class II device under product code HQC and regulation number 886.4670.
Is the AMO Diplomax/Opsys Console reusable or single-use?
The device data does not specify whether the AMO Diplomax/Opsys Console is designed for single-use or reuse. This information would typically be found in the device's instructions for use or product labeling.
What sizes or models of the AMO Diplomax/Opsys Console are available?
The device data does not provide information about different sizes or models of the AMO Diplomax/Opsys Console. All available specifications would be detailed in the product documentation provided by the manufacturer.
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: AMO DIPLOMAX/OPSYS CONSOLE (K971186) — FDA 510(k) | Innolitics, K971186 - AMO DIPLOMAX/OPSYS CONSOLE | FDA 510(k), PDF K971186 - Amo Diplomax/Opsys Console, AMO DIPLOMAX/OPSYS CONSOLE 510(k) K971186 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K971186 | Class II | Active |
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Manufacturer
- Manufacturer
- Allergan, Inc.
Sources (1)
- FDA 510(k) K971186 24 fields · synced Sep 28, 2026