Cryomatic MkII Console, Cryomatic MkII Probes, Disposable Cryo Probes
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Keeler Ltd
Identifiers
- 510(k) Number
- K131787 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 Cryomatic MkII Console and associated probes are cryophthalmic devices designed for controlled freezing of ocular tissues. Classified as an Ac-Powered Unit under FDA classification HRN, these devices deliver precise cryotherapy to the eye, utilising cryogenic probes for targeted treatment of conditions such as corneal dystrophies or retinal detachments.
The system comprises a reusable Cryomatic MkII Console paired with either reusable Cryomatic MkII Probes or single-use Disposable Cryo Probes. Supplied sterile or non-sterile as specified, the probes are intended for use in ophthalmic surgical settings, with compatibility confirmed for MRI environments. Authorised under FDA 510(k) clearance (K131787) and MDD compliance, the device adheres to regulatory standards for Class II medical devices, ensuring safe application in clinical practice.
Frequently asked questions
What types of ocular conditions is the Cryomatic MkII system designed to treat, and how does it achieve targeted therapy?
The Cryomatic MkII Console and probes are specifically designed for cryophthalmic procedures, delivering controlled freezing to ocular tissues. This targeted cryotherapy is primarily used for conditions like corneal dystrophies or retinal detachments, where precise temperature control is critical to treat affected areas without damaging surrounding tissue.
Are the Cryomatic MkII Probes reusable, and if so, how does their sterility status affect their use in surgery?
Yes, the Cryomatic MkII Probes are reusable, while the Disposable Cryo Probes are intended for single-use. Sterility status is configurable—probes can be supplied either sterile or non-sterile based on clinical requirements. For reusable probes, proper sterilization protocols must be followed between uses to ensure patient safety in ophthalmic surgical settings.
What are the key differences between the reusable Cryomatic MkII Probes and the Disposable Cryo Probes, and which should a clinician choose?
The reusable Cryomatic MkII Probes are designed for repeated use with proper sterilization, offering cost efficiency for high-volume settings. In contrast, the Disposable Cryo Probes eliminate reprocessing steps and reduce infection risks, ideal for single-patient procedures or facilities prioritizing convenience and sterility assurance. The choice depends on clinical workflow, budget, and infection control protocols.
Can the Cryomatic MkII system be used in MRI environments, and what considerations should clinicians keep in mind?
Yes, the Cryomatic MkII Console and probes are explicitly designed with MRI compatibility in mind, allowing for use in MRI environments without interference. Clinicians should ensure proper grounding and follow MRI safety protocols to avoid electromagnetic interference, as the system’s cryogenic function relies on precise temperature control.
How is the regulatory approval for the Cryomatic MkII system structured, and what does the FDA’s “Special” clearance type indicate?
The Cryomatic MkII system holds FDA 510(k) clearance (K131787) under the product code HRN, classified as an Ac-Powered Unit for ophthalmic use. The ‘Special’ clearance type indicates a more rigorous review process, often involving a comparison to a predicate device (substantially equivalent) and advisory committee input from the Ophthalmic Panel (OP). This ensures the device meets stringent safety and effectiveness standards for cryophthalmic applications.
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 (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K131787 | Class II | Active |
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Manufacturer
- Manufacturer
- Keeler Ltd
- FDA Applicant
- Keeler, Ltd.
Sources (2)
- FDA 510(k) K131787 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026