510(k) · Cleared
ClearedFreddo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda · GEX Powered Laser Surgical Instrument
Cleared on Oct 18, 2024 as substantially equivalent to K060395 (Zimmer Elektromedizin GmbH, 2006) after an 88-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Oct 18, 2024
- Review
- 88 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K963094 (1996). 37 ancestors in all, the oldest K904627 (1991). No later device cites it as a predicate yet.
- Root · 8 generations backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
- 7 generations backK972767 Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp. · 1997 · Recalled
- 6 generations backK974381 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- 5 generations backK981351 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- 4 generations backK990119 Epi-Star Surgical Laser SysterNidek, Inc. · 2000
- 3 generations backK013864 Modification to Epi-Star Surgical Laser System, M0DEL DS-60Nidek, Inc. · 2002
- 2 generations backK040727 CRYO 5Zimmer Elektromedizin GmbH · 2004
- 1 generation backK060395 Cryo, Model V6.0Zimmer Elektromedizin GmbH · 2006
- This deviceK242132 FreddoFabinject Lndustria E Comercio Lmportacao E Exportacao Ltda · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K963094 | Cynosure Photogenica LP Dermatological Vascular Lesion Laser | Cynosure, Inc. | 1996 | — |
| −7 | K972767 | Candela Gentlelase GL Dermatological Vascular Lesion Laser | Candela Corp. | 1997 | 1 |
| −6 | K974381 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| −5 | K981351 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| −4 | K990119 | Epi-Star Surgical Laser Syster | Nidek, Inc. | 2000 | — |
| −3 | K013864 | Modification to Epi-Star Surgical Laser System, M0DEL DS-60 | Nidek, Inc. | 2002 | — |
| −2 | K040727 | CRYO 5 | Zimmer Elektromedizin GmbH | 2004 | — |
| −1 | K060395 | Cryo, Model V6.0 | Zimmer Elektromedizin GmbH | 2006 | — |
| 0 (this device) | K242132 | Freddo | Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060395 | Cryo, Model V6.0Summary page 5…aser Surgical Instrument DEVICE CLASSIFICATION: Class II, 21 CFR §878.4810 PRODUCT CODE: GEX III. PREDICATE DEVICE: Cryo V6.0 (K060395) IV. DEVICE DESCRIPTION: The Freddo is a non-invasive therapeutic device. The cold air therapy device cools and dehumidifies t… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 37 ancestors has a recall of any class.
- 4 other devices also cite its predicate K060395.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242132 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242132: Freddo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K242132
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026