# K250742: Focused Cryotherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Focused Cryo, Inc.
- Decided: Dec 9, 2025 after 273 days
- Product code: GEH (Unit, Cryosurgical, Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4350
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K926514 (1993). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201588: CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice, Varian Medical Systems, Inc. (2020) Summary page 6.
- K230551: Visual-ICE Cryoablation System, Boston Scientific Corporation (2023) Summary page 6.

## Indications for use
The Focused Cryotherapy System is intended for cryoablative destruction of tissue during surgical procedures. The Focused Cryotherapy System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, nerves, tumors, and skin lesions. In addition, the system is intended for use in the following indications: Urology * Ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia (BPH) Oncology * Ablation of cancerous or malignant tissue and benign tumors, and palliative intervention. Palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy Dermatology * Ablation or freezing of skin cancers and other cutaneous disorders * Destruction of warts or lesions, 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, actinic and seborrheic keratosis, cavernous hemangiomas, peri-anal condylomata, and palliation of tumors of the skin Gynecology * Ablation of malignant neoplasia or benign dysplasia of the female genitalia General surgery * Palliation of tumors of the rectum, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas ENT * Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth Thoracic Surgery * (with the exception of cardiac tissue) Proctology * Ablation of benign or malignant growths of the anus or rectum Neurology * Freezing of nerve tissue in pain management/cryoanalgesia

Source page: https://510kreport.com/device/K250742
Methodology: https://510kreport.com/methodology