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TULSA-Pro System

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K230692

by Profound Medical Inc.

Identifiers

510(k) Number
K230692 FDA 510(k)
FDA Product Code
PLP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.4340 FDA 510(k)
Regulation Number
876.4340 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The TULSA-Pro System is a High Intensity Focused Ultrasound (HIFU) device designed for prostate tissue ablation. It employs focused ultrasound energy to precisely target and treat benign prostatic hyperplasia (BPH) or localized prostate cancer by inducing thermal ablation without incisions or radiation.

This system is intended for use in urology and gastroenterology settings, supplied as a reusable medical device. It is not sterile upon delivery and requires appropriate preparation and maintenance as per manufacturer guidelines. The device is classified as Class II under FDA regulations and is authorized via 510(k) clearance, adhering to the Medical Device Directive (MDD) standards. Multiple registration numbers and FEI numbers are associated with its regulatory compliance.

Frequently asked questions

What clinical specialties is the TULSA-Pro System primarily used in, and how does it differ from traditional prostate treatments?

The TULSA-Pro System is designed for use in urology and gastroenterology settings, where it targets prostate tissue ablation for conditions like benign prostatic hyperplasia (BPH) or localized prostate cancer. Unlike traditional treatments such as surgery or radiation, it uses high-intensity focused ultrasound (HIFU) to precisely deliver thermal energy, eliminating the need for incisions or radiation exposure while maintaining localized precision.

Is the TULSA-Pro System reusable, and what preparation is required before first use?

Yes, the TULSA-Pro System is a reusable medical device and is not sterile upon delivery. Before first use, it must undergo appropriate cleaning, sterilization, and maintenance as outlined in the manufacturer’s guidelines to ensure safe and effective operation. Sterilization procedures should align with standard medical device reprocessing protocols.

What regulatory pathways does the TULSA-Pro System follow, and how does it comply with international standards?

The TULSA-Pro System is authorized via FDA 510(k) clearance under the Medical Device Directive (MDD) and classified as a Class II device in the U.S. It adheres to regulatory compliance through multiple FEI numbers (e.g., 3007126306, 3012604011) and registration numbers (e.g., 9615058). These pathways ensure it meets safety and performance standards for use in prostate tissue ablation.

Are there different models or sizes available for the TULSA-Pro System, and how might they be selected?

The provided data does not specify distinct models or sizes for the TULSA-Pro System. However, as a High Intensity Focused Ultrasound (HIFU) device, its effectiveness may depend on prostate-specific parameters (e.g., volume, lesion location) rather than physical variations. Selection would typically be based on clinical guidelines, patient anatomy, and treatment indications, with manufacturer recommendations guiding optimal use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Profound Medical Inc.
FDA Applicant
Profound Medical, Inc.

Sources (2)

  • FDA 510(k) K230692 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026