FREDDO

Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda

Country / region:Brazil (BR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K242132
Device name
FREDDO
Country / region
Brazil(BR)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-07-22
Decision date
2024-10-18
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for 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.

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 Cold Air Device utilizes a compressor, evaporator, and fan to cool the patient's skin locally and contactless.

Summary parsed at:2026-06-01 05:29:04 UTC

Predicate devices

1

K242132 references 1 predicate/reference device

Cited as predicate

0

No later 510(k)s cite this device yet

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