510(k) · Cleared
ClearedCryoflow 700, Cryoflow 1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Uniphy Elektromedizin GmbH & Co. KG · GEX Powered Laser Surgical Instrument
Cleared on Mar 15, 2006 as substantially equivalent to K040727 (Zimmer Elektromedizin GmbH, 2004) after a 203-day review. Its family tree reaches back 7 generations to 1996.
- Decided
- Mar 15, 2006
- Review
- 203 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K963094 (1996). 36 ancestors in all, the oldest K904627 (1991). No later device cites it as a predicate yet.
- Root · 7 generations backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
- 6 generations backK972767 Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp. · 1997 · Recalled
- 5 generations backK974381 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- 4 generations backK981351 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- 3 generations backK990119 Epi-Star Surgical Laser SysterNidek, Inc. · 2000
- 2 generations backK013864 Modification to Epi-Star Surgical Laser System, M0DEL DS-60Nidek, Inc. · 2002
- 1 generation backK040727 CRYO 5Zimmer Elektromedizin GmbH · 2004
- This deviceK052310 Cryoflow 700, Cryoflow 1000Uniphy Elektromedizin GmbH & Co. KG · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K963094 | Cynosure Photogenica LP Dermatological Vascular Lesion Laser | Cynosure, Inc. | 1996 | — |
| −6 | K972767 | Candela Gentlelase GL Dermatological Vascular Lesion Laser | Candela Corp. | 1997 | 1 |
| −5 | K974381 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| −4 | K981351 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| −3 | K990119 | Epi-Star Surgical Laser Syster | Nidek, Inc. | 2000 | — |
| −2 | K013864 | Modification to Epi-Star Surgical Laser System, M0DEL DS-60 | Nidek, Inc. | 2002 | — |
| −1 | K040727 | CRYO 5 | Zimmer Elektromedizin GmbH | 2004 | — |
| 0 (this device) | K052310 | Cryoflow 700, Cryoflow 1000 | Uniphy Elektromedizin GmbH & Co. KG | 2006 | — |
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 |
|---|---|---|---|
| * | K040727 | CRYO 5Summary page 1…relief for injections. Substantial equivalence claim to the following legally marketed device: Cryo 5 (Zimmer). K040727 Summary of substantial equivalence: The Uniphy Cryoflow 700 and Cryflow 1000 are substantially equivalent to the compared device… | 2004 |
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 10 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 36 ancestors has a recall of any class.
- 3 other devices also cite its predicate K040727.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Cryoflow 700 and Cryoflow 1000 are intended 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/K052310 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052310: Cryoflow 700, Cryoflow 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052310
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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