510(k) · Cleared
ClearedMyoscience Cryo-Touch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Myoscience, Inc. · GEH Unit, Cryosurgical, Accessories
Cleared on Mar 20, 2009 as substantially equivalent to K024009 (H&O Equipments, Nv/Sa, 2003) and 1 other predicate after a 115-day review. Its family tree reaches back 1 generation to 2003. 11 later devices descend from it.
- Decided
- Mar 20, 2009
- Review
- 115 days
- Class
- Class II
- Product code
- GEH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K024009 (2003). 2 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK024009 CryoprobeH&O Equipments, Nv/Sa · 2003
- This deviceK083493 Myoscience Cryo-TouchMyoscience, Inc. · 2009
- Descendant · cites it directly · 10 of its ownK100447 Myoscience Cryo-TouchMyoscience, Inc. · 2010
- Descendant · 2 generations on · 9 of its ownK102021 Cryo-Touch IIMyoscience, Inc. · 2010
- Descendant · cites it directly · 8 of its ownK120415 Cryo-Touch IiiMyoscience, Inc. · 2012
- Descendant · 2 generations on · 7 of its ownK123516 Cryo-Touch IVMyoscience, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 6 of its ownK133453 IoveraMyoscience, Inc. · 2014
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K100447Myoscience Cryo-TouchMyoscience, Inc. · 2010 · cites it directly10descendants
- K102021Cryo-Touch IIMyoscience, Inc. · 2010 · 2 generations on9descendants
- K120415Cryo-Touch IiiMyoscience, Inc. · 2012 · cites it directly8descendants
- K123516Cryo-Touch IVMyoscience, Inc. · 2013 · 2 generations on7descendants
- K133453IoveraMyoscience, Inc. · 2014 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K024009 | Cryoprobe | H&O Equipments, Nv/Sa | 2003 | — |
| 0 (this device) | K083493 | Myoscience Cryo-Touch | Myoscience, Inc. | 2009 | — |
| +1 | K100447 | Myoscience Cryo-Touch | Myoscience, Inc. | 2010 | — |
| +2 | K102021 | Cryo-Touch II | Myoscience, Inc. | 2010 | — |
| +1 | K120415 | Cryo-Touch Iii | Myoscience, Inc. | 2012 | — |
| +2 | K123516 | Cryo-Touch IV | Myoscience, Inc. | 2013 | 1 |
| +3 | K133453 | Iovera | Myoscience, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 GEH? 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 GEH device
- #1 K211099 Freeze’n Clear Skin Clinic Warts & Tagsscore 25.4 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K024009 | CryoprobeSummary page 1…: Cryosurgical unit and accessories (21 CFR 878.4350) Device Proprietary Name: I MyoScience Cryo-Touch a. Predicate Device Information: * CryoProbe (K024009), H&O Equipments NV/SA, Inc * CryoShape (K060928), Etgar Group H.M.Y.A. Ltd b. Date Summary Prepared March 17, 2009 c. Descr… | 2003 |
| * | K060928 | CryoshapeSummary page 1…878.4350) Device Proprietary Name: I MyoScience Cryo-Touch a. Predicate Device Information: * CryoProbe (K024009), H&O Equipments NV/SA, Inc * CryoShape (K060928), Etgar Group H.M.Y.A. Ltd b. Date Summary Prepared March 17, 2009 c. Description of Device The MyoScience Cryo-Touch device is… | 2006 |
What descends from it? (11)
See all 112 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?
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GEH
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEH
77in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEH
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GEH
171in 2025
MAUDE reports naming product code GEH, 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 | 6 | 71 | 3 | 23 |
| 2008 | 1 | — | 2 | 29 |
| 2009 | 4 | 121 | 13 | 21 |
| 2010 | 4 | 86 | 4 | 173 |
| 2011 | 7 | 91 | 0 | 61 |
| 2012 | 4 | 96 | 3 | 91 |
| 2013 | 4 | 76 | 0 | 91 |
| 2014 | 6 | 42 | 2 | 57 |
| 2015 | 11 | 72 | 0 | 97 |
| 2016 | 15 | 60 | 0 | 143 |
| 2017 | 12 | 83 | 0 | 216 |
| 2018 | 6 | 42 | 1 | 208 |
| 2019 | 6 | 115 | 1 | 455 |
| 2020 | 8 | 113 | 37 | 277 |
| 2021 | 6 | 206 | 0 | 213 |
| 2022 | 6 | 56 | 0 | 230 |
| 2023 | 8 | 136 | 2 | 164 |
| 2024 | 9 | 85 | 0 | 141 |
| 2025 | 10 | 77 | 0 | 171 |
| 2026 | 8 | 148 | 2 | — |
What is it indicated for?
The MyoScience Cryo-Touch device is intended to destroy tissue during surgical procedures by applying freezing cold.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083493 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083493: Myoscience Cryo-Touch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083493
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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