510(k) · Cleared
Recalled · Class II · 2019Icesence 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
IceCure Medical, Ltd. · GEH Unit, Cryosurgical, Accessories
Cleared on Nov 29, 2010 as substantially equivalent to K072883 (Arbel Medical, Ltd., 2007) and 2 other predicates after a 102-day review. Its family tree reaches back 7 generations to 2001. 25 later devices descend from it. It has been recalled once.
- Decided
- Nov 29, 2010
- Review
- 102 days
- Class
- Class II
- Product code
- GEH
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 7 generations to K003811 (2001). 19 ancestors in all, the oldest K790187 (1979). 25 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK003811 Cryocare Surgical SystemEndocare, Inc. · 2001
- 6 generations backK020605 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002
- 5 generations backK021211 Modification to Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002
- 4 generations backK022314 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2002 · Recalled
- 3 generations backK052861 Modification to:Sanarus Visica Treatment System , Models VS2000Sanarus Medical, Inc. · 2005
- 2 generations backK061510 Sanarus Visica Treatment SystemSanarus Medical, Inc. · 2006
- 1 generation backK062896 V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models…Sanarus Medical, Inc. · 2007
- This deviceK102360 Icesence 3IceCure Medical, Ltd. · 2010
- Descendant · cites it directly · 20 of its ownK133258 Trufreeze SystemCSA Medical, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 19 of its ownK143625 truFreeze SystemCSA Medical, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 11 of its ownK150920 truFreeze SystemCSA Medical, Inc. · 2015
- Descendant · 3 generations on · 10 of its ownK152668 truFreeze SystemCSA Medical, Inc. · 2015
- Descendant · 4 generations on · 9 of its ownK160273 truFreeze SystemCsa Medial, Inc. · 2016
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K133258Trufreeze SystemCSA Medical, Inc. · 2014 · cites it directly20descendants
- K143625truFreeze SystemCSA Medical, Inc. · 2015 · 2 generations on19descendants
- K150920truFreeze SystemCSA Medical, Inc. · 2015 · 3 generations on11descendants
- K152668truFreeze SystemCSA Medical, Inc. · 2015 · 3 generations on10descendants
- K160273truFreeze SystemCsa Medial, Inc. · 2016 · 4 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K003811 | Cryocare Surgical System | Endocare, Inc. | 2001 | — |
| −6 | K020605 | Sanarus Visica Treatment System | Sanarus Medical, Inc. | 2002 | — |
| −5 | K021211 | Modification to Sanarus Visica Treatment System | Sanarus Medical, Inc. | 2002 | — |
| −4 | K022314 | Sanarus Visica Treatment System | Sanarus Medical, Inc. | 2002 | 1 |
| −3 | K052861 | Modification to:Sanarus Visica Treatment System , Models VS2000 | Sanarus Medical, Inc. | 2005 | — |
| −2 | K061510 | Sanarus Visica Treatment System | Sanarus Medical, Inc. | 2006 | — |
| −1 | K062896 | V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000… | Sanarus Medical, Inc. | 2007 | — |
| 0 (this device) | K102360 | Icesence 3 | IceCure Medical, Ltd. | 2010 | — |
| +1 | K133258 | Trufreeze System | CSA Medical, Inc. | 2014 | 1 |
| +2 | K143625 | truFreeze System | CSA Medical, Inc. | 2015 | 1 |
| +3 | K150920 | truFreeze System | CSA Medical, Inc. | 2015 | — |
| +3 | K152668 | truFreeze System | CSA Medical, Inc. | 2015 | — |
| +4 | K160273 | truFreeze System | Csa Medial, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1984 | 1 | 0 |
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K072883 | Ice-SenseSummary page 2…e-' 3 510(k) Summary 510(k) Submission Predicate Devices The lceSense3 System is substantially equivalent to the cleared IceSenserTM System (K072883), the cleared Galil Medical Seednet family (K052530) and Sanarus Medical's V2 Treatment System (K062896). Intended Use!/ Indicati… | 2007 |
| * | K052530 | Seednet, Seednet Gold, Cryohit, CryotheraSummary page 2…Predicate Devices The lceSense3 System is substantially equivalent to the cleared IceSenserTM System (K072883), the cleared Galil Medical Seednet family (K052530) and Sanarus Medical's V2 Treatment System (K062896). Intended Use!/ Indications fr Use The lceSense3 is intended for cryogenic d… | 2005 |
| * | K062896 | V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000, VP0600, VD0600Summary page 2…em is substantially equivalent to the cleared IceSenserTM System (K072883), the cleared Galil Medical Seednet family (K052530) and Sanarus Medical's V2 Treatment System (K062896). Intended Use!/ Indications fr Use The lceSense3 is intended for cryogenic destruction of tissue during surgical procedures. The… | 2007 |
What descends from it? (25)
See all 252 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 16, 2019 | Class II | Z-2650-2023 | Other | Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe) |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 6 months on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K133258 (CSA Medical, Inc., 2014) has gone furthest, with 20 descendants of its own.
How does its category compare?
All GEH devicesGEH Unit, Cryosurgical, Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 lceSense3 is intended for cryogenic destruction of tissue during surgical procedures. The IceSense3 is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, thoracic surgery, gynecology, oncology, proctology, and urology. The lceSense3 may be used with an ultrasound device to provide real-time visualization of the cryosurgical procedure. Umolopv * The system may be used to ablate prostatic tissue. * The system may be…
Read the full statement (313 words)
The lceSense3 is intended for cryogenic destruction of tissue during surgical procedures.
The IceSense3 is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, thoracic surgery, gynecology, oncology, proctology, and urology. The lceSense3 may be used with an ultrasound device to provide real-time visualization of the cryosurgical procedure.
Umolopv
* The system may be used to ablate prostatic tissue.
* The system may be used for the ablation of prostate tissue in cases of prostate cancer and benign prostatic hypetplasia
Oncoloav
* The system may be used for ablation of cancerous or malignant tissue.
* The system may be used for ablation of benign tumors.
* The system may be used for palliative intervention.
Dermatologi
* The system may be used for the ablation or freezing of skin cancers and other coetaneous disorders.
Gynecology
*The system may be used for the ablation of malignant neoplasia or benign dysplasia of the female genitalia.
General Surgery,
* The system may be used for the ablation of leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts actinic end seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions.
* The system may be used for the destruction of warts or lesions.
* The system may be used for the palliation of tumors of the oral cavity, rectum, and skin.
* The system may be used for Ablation of breast fibroadenomas
Thoracic Sureaer
* The system may be used for the ablation of arrhythmic cardiac tissue.
* The system may be used for the ablation of cancerous lesions
Proctology
* The system may be used for the ablation of benign or malignant growths of the anus and rectum
* The systems may be used for the ablation of hemorrhoids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102360 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102360: Icesence 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102360
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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