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Nuance Cryo-Freeze Spray

FDA 510(k)

Class II (US FDA 510(k))

510(k) K130995

by Nuance Medical, Llc

Identifiers

510(k) Number
K130995 FDA 510(k)
FDA Product Code
GEH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4350 FDA 510(k)
Regulation Number
878.4350 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Nuance Cryo-Freeze Spray is a cryosurgical accessory device. It is designed to function as a unit for cryosurgical applications.

This device is authorized under FDA 510(k) clearance K130995. It is classified as a class 2 medical device under regulation number 878.4350.

Frequently asked questions

What is the intended use of the Nuance Cryo-Freeze Spray?

The Nuance Cryo-Freeze Spray is designed to function as a cryosurgical accessory device for use in cryosurgical applications.

Is this device authorized for use in the United States?

Yes, the Nuance Cryo-Freeze Spray is authorized under FDA 510(k) clearance K130995.

How is this device classified by the FDA?

The device is classified as a class 2 medical device under regulation number 878.4350, which pertains to cryosurgical accessories.

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

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Manufacturer

Manufacturer
Nuance Medical, Llc

Sources (1)

  • FDA 510(k) K130995 24 fields · synced Oct 6, 2026