# K242132: Freddo

- Pathway: 510(k) (Traditional)
- Applicant: Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda
- Decided: Oct 18, 2024 after 88 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K963094 (1996). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060395: Cryo, Model V6.0, Zimmer Elektromedizin GmbH (2006) Summary page 5.

## 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.

Source page: https://510kreport.com/device/K242132
Methodology: https://510kreport.com/methodology