510(k) · Cleared
ClearedCryo, Model V6.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Elektromedizin GmbH · GEX Powered Laser Surgical Instrument
Cleared on Feb 24, 2006 as substantially equivalent to K040727 (Zimmer Elektromedizin GmbH, 2004) after a 9-day review. Its family tree reaches back 7 generations to 1996. 9 later devices descend from it.
- Decided
- Feb 24, 2006
- Review
- 9 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). 9 later devices descend from it, 5 citing it directly.
- 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 deviceK060395 Cryo, Model V6.0Zimmer Elektromedizin GmbH · 2006
- Descendant · cites it directly · 2 of its ownK220020 Cryo 7Zimmer Medizinsysteme GmbH · 2022
- Descendant · cites it directly · 2 of its ownK083008 CoolskinElbio Co., Ltd. · 2009
- Descendant · 2 generations on · 1 of its ownK233416 Cryojet Plus (SHE-ACP001-1)Beijing Sano Laser S&T Development Co.,Ltd · 2024
- Descendant · 2 generations on · 1 of its ownK213294 Dermal Cooling SystemR2 Technologies, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK080735 CryominiZimmer Elektromedizin GmbH · 2008
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K220020Cryo 7Zimmer Medizinsysteme GmbH · 2022 · cites it directly2descendants
- K083008CoolskinElbio Co., Ltd. · 2009 · cites it directly2descendants
- K233416Cryojet Plus (SHE-ACP001-1)Beijing Sano Laser S&T Development Co.,Ltd · 2024 · 2 generations on1descendant
- K213294Dermal Cooling SystemR2 Technologies, Inc. · 2022 · 2 generations on1descendant
- K080735CryominiZimmer Elektromedizin GmbH · 2008 · cites it directly1descendant
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) | K060395 | Cryo, Model V6.0 | Zimmer Elektromedizin GmbH | 2006 | — |
| +1 | K220020 | Cryo 7 | Zimmer Medizinsysteme GmbH | 2022 | — |
| +1 | K083008 | Coolskin | Elbio Co., Ltd. | 2009 | — |
| +2 | K233416 | Cryojet Plus (SHE-ACP001-1) | Beijing Sano Laser S&T Development Co.,Ltd | 2024 | — |
| +2 | K213294 | Dermal Cooling System | R2 Technologies, Inc. | 2022 | — |
| +1 | K080735 | Cryomini | Zimmer Elektromedizin GmbH | 2008 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 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…anesthetic relief for injections. SL .ntial Equivalence Claim to the following legally marketed devices: 1. Cryo 5 (Zimmer) K040727 Page 1of 2 Author: A.Pelraschka… | 2004 |
What descends from it? (9)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 36 ancestors has a recall of any class.
- Of its descendants, K220020 (Zimmer Medizinsysteme GmbH, 2022) has gone furthest, with 2 descendants of its own.
- 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 Cryo V6.0 Cold Air Device is 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/K060395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060395: Cryo, Model V6.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060395
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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