Cavitron/Kelman Phaco-Emulsifier Aspirator 9001
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K852271 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 Cavitron/Kelman Phaco-Emulsifier Aspirator 9001 is an ac-powered vitreous aspiration and cutting instrument designed for ophthalmic surgery. It combines emulsification and aspiration to remove the eye’s natural lens during cataract procedures, facilitating precise tissue fragmentation and fluid management to restore visual clarity.
This device is intended for single-use in sterile operating environments and is classified as a Class II medical device under FDA regulations. Supplied as a reusable system with disposable components, it requires proper calibration and maintenance to ensure MRI safety and optimal performance. Authorized under FDA 510(k) clearance (K852271), it adheres to regulatory standards for ophthalmic instruments, including compliance with 21 CFR 886.4150.
Frequently asked questions
What is the primary purpose of the Cavitron/Kelman Phaco-Emulsifier Aspirator 9001 in ophthalmic surgery?
The Cavitron/Kelman Phaco-Emulsifier Aspirator 9001 is designed specifically for cataract surgery to remove the eye’s natural lens. It combines emulsification and aspiration to break down and efficiently evacuate lens tissue, helping restore visual clarity during the procedure. Its dual-function design ensures precise tissue fragmentation and fluid management.
Is this device intended for single-use or reusable applications, and what components are disposable?
The Cavitron/Kelman Phaco-Emulsifier Aspirator 9001 is supplied as a reusable system, but it requires the use of disposable components for single-use in sterile environments. This ensures compliance with surgical hygiene standards while maintaining the longevity of the core instrument.
What regulatory pathway was followed for FDA clearance of this device, and what class does it fall under?
The Cavitron/Kelman Phaco-Emulsifier Aspirator 9001 received FDA 510(k) clearance (K852271) under a Traditional 510(k) review, determined to be *substantially equivalent* to a predicate device. It is classified as a Class II medical device under FDA regulations, adhering to 21 CFR 886.4150 for ophthalmic instruments.
Does this device require any special handling or maintenance to ensure MRI safety?
Yes, the Cavitron/Kelman Phaco-Emulsifier Aspirator 9001 requires proper calibration and maintenance to ensure MRI safety. Since it is used in operating environments where MRI compatibility may be a concern, adherence to manufacturer guidelines is critical to prevent interference or hazards during imaging procedures.
What types of power does this device use, and is it compatible with standard ophthalmic surgical setups?
The Cavitron/Kelman Phaco-Emulsifier Aspirator 9001 is ac-powered, meaning it requires access to standard electrical outlets. Its design aligns with typical ophthalmic surgical setups, where power and aspiration systems are integrated into the operating room infrastructure, ensuring seamless integration for cataract procedures.
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: PDF K852271 - Cavitron/Kelman Phaco-emulsifier Aspirator, 9001, CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA (K842979) — FDA 510 (k ..., Cavitron/Kelman Phacoemulsifier Aspirator, Univ., CAVITRON/KELMAN PHACO-EMULSIFIER ASPIRA 510(k) K842979 - 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 | K852271 | Class II | Active |
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Manufacturer
- Manufacturer
- Coopervision Inc.
- FDA Applicant
- CooperVision, Inc.
Sources (1)
- FDA 510(k) K852271 24 fields · synced Sep 19, 2026