# K102360: Icesence 3

- Pathway: 510(k) (Traditional)
- Applicant: IceCure Medical, Ltd.
- Decided: Nov 29, 2010 after 102 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K003811 (2001). 19 ancestors in all.
25 later devices descend from it; 2 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072883: Ice-Sense, Arbel Medical, Ltd. (2007) Summary page 2.
- K052530: Seednet, Seednet Gold, Cryohit, Cryothera, Galil Medical, Ltd. (2005) Summary page 2.
- K062896: V2 Treatment System (V2 Console, V2 Ice Probe, V2 Dewars) Models; VS3000, VP0600, VD0600, Sanarus Medical, Inc. (2007) Summary page 2.

## Most influential descendants
- K133258: Trufreeze System (2014), 20 descendants of its own
- K143625: truFreeze System (2015), 19 descendants of its own
- K150920: truFreeze System (2015), 11 descendants of its own
- K152668: truFreeze System (2015), 10 descendants of its own
- K160273: truFreeze System (2016), 9 descendants of its own

## Recalls of this device
- Sep 16, 2019 · Class II · Z-2650-2023: Updated User Manual DSR3200000 Rev. E to include the safety guidelines in case of any mechanical damage (e.g. bent cryoprobe)

## Indications for use
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.

Source page: https://510kreport.com/device/K102360
Methodology: https://510kreport.com/methodology