FREDDO
Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda
Country / Region:Brazil (BR)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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
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K242132 references 1 predicate/reference device
Cited as predicate
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