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510(k) Data Aggregation
K Number
K242132Device Name
FREDDO
Date Cleared
2024-10-18
(88 days)
Product Code
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Fabinject lndustria e Comercio lmportacao e Exportacao Ltda
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Freddo is indicated to be used to: Minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.
Device Description
The Freddo is a non-invasive therapeutic device. The cold air therapy device cools and dehumidifies the air, which can be used to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections. The cold air therapy device is intended to cool the patient's skin locally and is intended to be used contactless. The subject Freddo device is substantially equivalent as the currently cleared Cryo 6 (K060395).
The mechanical assembling consists of a housing, a chassis with 4 rotating rollers and a shelf plate. The chassis includes all technical components, like compressor, evaporator, condenser, fans, and all electrical power components. On the upper front cover, the user interface control it operated via membrane keyboard.
The software controls the device initialization, the hardware components for the cooling circuit as well as the user interface. The user interface can be controlled via membrane keyboard. The software controls the device initialization, the hardware components for the cooling circuit as well as the user interface.
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