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Converter System
FDA 510(k)Class II (US FDA 510(k))
510(k) K894248
by Mira, Inc.
Identifiers
- 510(k) Number
- K894248 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 Converter System is an ophthalmic instrument used for vitreous aspiration and cutting. It is an AC-powered device designed for use in ophthalmic procedures.
The Converter System is supplied as a reusable device and is not MRI safe. It is authorized under FDA 510K clearance with product code HQE and device class 2.
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
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K894248 | Class II | Active |
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Manufacturer
- Manufacturer
- Mira, Inc.
Sources (1)
- FDA 510(k) K894248 24 fields · synced Sep 23, 2026