Cooper Vision I/A System III Model 1500
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K822220 FDA 510(k)
- FDA Product Code
- HQE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.4150 FDA 510(k)
- Regulation Number
- 886.4150 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cooper Vision I/A System III Model 1500 is an instrument for vitreous aspiration and cutting, designed for ophthalmic procedures. It is an AC-powered device that assists in the removal and cutting of vitreous material during eye surgeries.
This device is supplied as a reusable instrument and is classified under product code HQE. It received FDA 510(k) clearance with number K822220 on October 6, 1982, and is regulated under 886.4150. The device is intended for use in ophthalmic settings and is manufactured by CooperVision, Inc.
Frequently asked questions
What is the Cooper Vision I/A System III Model 1500 used for?
The Cooper Vision I/A System III Model 1500 is an AC-powered instrument designed for vitreous aspiration and cutting during ophthalmic procedures. It assists surgeons in removing and cutting vitreous material during eye surgeries.
Is the Cooper Vision I/A System III Model 1500 a single-use or reusable instrument?
The Cooper Vision I/A System III Model 1500 is supplied as a reusable instrument. It is designed to be sterilized and used multiple times in ophthalmic settings, following proper sterilization protocols between uses.
What regulatory approvals does the Cooper Vision I/A System III Model 1500 have?
The Cooper Vision I/A System III Model 1500 received FDA 510(k) clearance with number K822220 on October 6, 1982. It is classified under product code HQE and is regulated under 886.4150. The device is intended for use in ophthalmic settings.
How is the Cooper Vision I/A System III Model 1500 supplied?
The Cooper Vision I/A System III Model 1500 is supplied as a reusable instrument. It is manufactured by CooperVision, Inc. and is designed for use in ophthalmic settings where vitreous aspiration and cutting procedures are performed.
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: COOPER VISION I/A SYSTEM III MODEL 1500 - Innolitics, PDF K822220 - Cooper Vision I/A System Iii Model 1500, COOPER VISION I/A SYSTEM III MODEL 1500 510(k) K822220 - 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 | K822220 | Class II | Active |
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Manufacturer
- Manufacturer
- Coopervision Inc.
- FDA Applicant
- CooperVision, Inc.
Sources (1)
- FDA 510(k) K822220 24 fields · synced Sep 27, 2026