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Cryo 7

FDA 510(k)

Class II (US FDA 510(k))

510(k) K220020

by Zimmer MedizinSysteme GmbH

Identifiers

510(k) Number
K220020 FDA 510(k)
FDA Product Code
GEX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Cryo 7 is a cryotherapy device designed for contact-free cold air therapy, delivering controlled cooling at temperatures as low as -30°C. It is classified as a cryotherapy unit (product code GEX) and is intended for therapeutic applications involving tissue and skin cooling. The system leverages cold air to provide precise, non-invasive treatment for both acute and chronic conditions. Its design emphasizes efficiency and patient comfort through consistent temperature regulation.

The Cryo 7 is supplied as a reusable medical device and is intended for use in clinical settings such as plastic surgery and dermatology. It operates under FDA clearance (K220020) as a Special 510(k) submission, classified under the General, Plastic Surgery advisory committee. The device requires proper maintenance and storage to ensure functionality and sterility where applicable. No specific MRI safety or single-use designation is indicated in the regulatory data.

Frequently asked questions

What is the Cryo 7 cryotherapy device used for?

The Cryo 7 is designed for therapeutic applications involving tissue and skin cooling. It uses controlled cold air delivery (down to -30°C) to provide non-invasive treatment for both acute and chronic conditions, making it suitable for clinical settings like plastic surgery and dermatology. The device ensures patient comfort through consistent temperature regulation, targeting conditions where localized cooling is beneficial.

Is the Cryo 7 a single-use or reusable device?

The Cryo 7 is classified as a reusable medical device. While it is intended for clinical use, proper maintenance and storage protocols must be followed to ensure its functionality and hygiene over repeated applications. Reusability is common for cryotherapy units in controlled environments where sterility can be maintained.

What regulatory clearance does the Cryo 7 have?

The Cryo 7 holds FDA clearance under the Special 510(k) pathway, with clearance number K220020. It was reviewed by the General, Plastic Surgery advisory committee and classified under product code GEX (cryotherapy units). This clearance confirms its substantial equivalence to a predicate device for the intended therapeutic uses.

How should the Cryo 7 be stored to maintain performance?

The Cryo 7 requires proper storage to preserve its functionality and ensure long-term reliability. Since it is reusable, storage should follow manufacturer guidelines to prevent contamination or damage. Specific instructions may include keeping the device in a clean, dry environment away from extreme temperatures or direct sunlight, as well as adhering to any maintenance schedules provided to avoid degradation of components.

Can the Cryo 7 be used in MRI environments?

The provided regulatory data does not specify MRI safety for the Cryo 7. If MRI compatibility is required, additional verification or manufacturer documentation would be necessary to confirm whether the device can be safely used in such environments without interference or risk. Always consult the device’s technical specifications or contact the manufacturer for MRI-related inquiries.

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: Cryo 7 | Zimmer MedizinSysteme GmbH, Cryo 7 | Zimmer MedizinSysteme, Cryo 7 Cold Air Chiller Device - Zimmer MedizinSystems

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Zimmer MedizinSysteme GmbH

Sources (1)

  • FDA 510(k) K220020 24 fields · synced Oct 1, 2026