Identifiers
- 510(k) Number
- K230858 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 QUATERA 700 is a phacoemulsification and anterior segment surgical platform designed to provide stability during cataract surgery. It features the patented QUATTRO Pump technology that allows synchronized infusion and aspiration changes in real time, actively compensating for incision leakage to maintain chamber stability during occlusion.
The device is manufactured by Carl Zeiss Meditec AG and has received FDA 510(k) clearance with the product code HQC. It is intended for use in ophthalmic surgical procedures and is supplied in various models as indicated by the registration numbers. The device is not described as single-use or reusable, and no specific MRI safety information is provided in the data.
Frequently asked questions
What is the primary function of the QUATERA 700?
The QUATERA 700 is a surgical platform designed for phacoemulsification and anterior segment ophthalmic procedures. It is engineered to provide surgical stability by using patented QUATTRO Pump technology to synchronize infusion and aspiration in real time, which compensates for incision leakage.
How is the QUATERA 700 regulated?
The device has received FDA 510(k) clearance under the product code HQC, which corresponds to phacofragmentation units. It is classified as a Class 2 medical device under regulation number 886.4670.
Are there different versions of this surgical platform?
Yes, the QUATERA 700 is supplied in various models. These specific model variations are identified by their respective registration numbers as documented by the manufacturer, Carl Zeiss Meditec AG.
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: Zeiss Quatera 700, Zeiss Quatera 700, ZEISS QUATERA 700 - Tradintek, PDF Zeiss Quatera 700, Redefining Phacoemulsification Expectations with the ZEISS QUATERA 700
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K230858 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Carl Zeiss Meditec AG
- FDA Applicant
- Carl Zeiss Meditec, AG
Sources (1)
- FDA 510(k) K230858 24 fields · synced Oct 6, 2026