Identifiers
- 510(k) Number
- K200911 FDA 510(k)
- FDA Product Code
- HRN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.4170 FDA 510(k)
- Regulation Number
- 886.4170 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MIRA Adapter is a mechanical accessory classified as a Cryophthalmic, Ac-Powered Unit (HRN product code) designed to facilitate the connection of the PHAKOS Disposable Retinal Cryo Probe to multiple cryosurgery generators. It serves as a universal interface, enabling compatibility between the probe and third-party systems while maintaining a fixed attachment to the generator console.
This device is supplied as a reusable accessory, packaged in a box of 10 double-pouch sterilised units, and is intended for ophthalmic use. It adheres to FDA 510(k) clearance (K200911) under substantial equivalence to predicate devices, with no explicit MRI safety or sterility classification noted beyond standard medical device packaging. Compliance with ISO and CE0459 standards is documented, ensuring regulatory alignment for clinical applications.
Frequently asked questions
What is the primary purpose of the MIRA Adapter in ophthalmic procedures?
The MIRA Adapter acts as a universal mechanical interface to connect the PHAKOS Disposable Retinal Cryo Probe to various cryosurgery generators. Its design ensures compatibility between the probe and third-party systems while providing a secure, fixed attachment to the generator console, streamlining cryophthalmic procedures.
How is the MIRA Adapter supplied, and is it intended for single-use or reuse?
The MIRA Adapter is supplied as a reusable accessory, packaged in a box containing 10 double-pouch sterilized units. It is not designed for single-use, allowing for repeated sterilization and clinical application as needed.
What regulatory standards does the MIRA Adapter comply with, and how was its FDA clearance determined?
The MIRA Adapter complies with ISO standards and CE0459, ensuring regulatory alignment for clinical use. Its FDA clearance (K200911) was granted under a traditional 510(k) pathway, with a decision of substantial equivalence to predicate devices in the cryophthalmic, AC-powered unit category (HRN).
Does the MIRA Adapter have any special handling requirements, such as storage or sterility considerations?
The MIRA Adapter is supplied in a sterilized double-pouch packaging, ensuring sterility upon receipt. Since it is reusable, it must be properly sterilized between uses following standard medical device reprocessing protocols. Storage should follow manufacturer guidelines to maintain functionality and sterility.
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: MIRA Adapter by Phakos | FDA 510 (k) Summary, Adapter cryo probe - Phakos, MIRA Adapter (K200911) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200911 | Class II | Active |
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Manufacturer
- Manufacturer
- Phakos
Sources (1)
- FDA 510(k) K200911 24 fields · synced Sep 19, 2026