510(k) · Cleared
ClearedCynosure Smartcool Family Cold Air Device: Smartcool, Smartcool 6 and Cryo C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cynosure, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Apr 14, 2009 as substantially equivalent to K040727 (Zimmer Elektromedizin GmbH, 2004) and 2 other predicates after a 36-day review. Its family tree reaches back 9 generations to 1996.
- Decided
- Apr 14, 2009
- Review
- 36 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K963094 (1996). 38 ancestors in all, the oldest K904627 (1991). No later device cites it as a predicate yet.
- Root · 9 generations backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
- 5 generations between
- 3 generations backK040727 CRYO 5Zimmer Elektromedizin GmbH · 2004
- 2 generations backK060395 Cryo, Model V6.0Zimmer Elektromedizin GmbH · 2006
- 1 generation backK080735 CryominiZimmer Elektromedizin GmbH · 2008
- This deviceK090618 Cynosure Smartcool Family Cold Air Device: Smartcool, Smartcool 6…Cynosure, Inc. · 2009
Show all 9 generations
- Root · 9 generations backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
- 8 generations backK972767 Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp. · 1997 · Recalled
- 7 generations backK974381 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- 6 generations backK981351 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- 5 generations backK990119 Epi-Star Surgical Laser SysterNidek, Inc. · 2000
- 4 generations backK013864 Modification to Epi-Star Surgical Laser System, M0DEL DS-60Nidek, Inc. · 2002
- 3 generations backK040727 CRYO 5Zimmer Elektromedizin GmbH · 2004
- 2 generations backK060395 Cryo, Model V6.0Zimmer Elektromedizin GmbH · 2006
- 1 generation backK080735 CryominiZimmer Elektromedizin GmbH · 2008
- This deviceK090618 Cynosure Smartcool Family Cold Air Device: Smartcool, Smartcool 6…Cynosure, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K963094 | Cynosure Photogenica LP Dermatological Vascular Lesion Laser | Cynosure, Inc. | 1996 | — |
| −8 | K972767 | Candela Gentlelase GL Dermatological Vascular Lesion Laser | Candela Corp. | 1997 | 1 |
| −7 | K974381 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| −6 | K981351 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| −5 | K990119 | Epi-Star Surgical Laser Syster | Nidek, Inc. | 2000 | — |
| −4 | K013864 | Modification to Epi-Star Surgical Laser System, M0DEL DS-60 | Nidek, Inc. | 2002 | — |
| −3 | K040727 | CRYO 5 | Zimmer Elektromedizin GmbH | 2004 | — |
| −2 | K060395 | Cryo, Model V6.0 | Zimmer Elektromedizin GmbH | 2006 | — |
| −1 | K080735 | Cryomini | Zimmer Elektromedizin GmbH | 2008 | — |
| 0 (this device) | K090618 | Cynosure Smartcool Family Cold Air Device: Smartcool, Smartcool 6 and Cryo C | Cynosure, Inc. | 2009 | — |
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? (3)
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…m Classification Name: Instrument, surgical, powered, laser Class 11 (21 CFR 878.4810) Equivalent Device: Cryo 5 (K040727), Cryo V6 (K060395), and CryoMini (K080735) Device Description: The SmartCool family cold air device consists of a re… | 2004 |
| * | K060395 | Cryo, Model V6.0Summary page 1…me: Instrument, surgical, powered, laser Class 11 (21 CFR 878.4810) Equivalent Device: Cryo 5 (K040727), Cryo V6 (K060395), and CryoMini (K080735) Device Description: The SmartCool family cold air device consists of a refrigeration unit… | 2006 |
| * | K080735 | CryominiSummary page 1…t, surgical, powered, laser Class 11 (21 CFR 878.4810) Equivalent Device: Cryo 5 (K040727), Cryo V6 (K060395), and CryoMini (K080735) Device Description: The SmartCool family cold air device consists of a refrigeration unit… | 2008 |
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 13 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 38 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. 2009, 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 SmartCool family cold air device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090618 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090618: Cynosure Smartcool Family Cold Air Device: Smartcool, Smartcool 6 and Cryo C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090618
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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