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CellFX System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K221671

by Pulse Biosciences, Inc.

Identifiers

510(k) Number
K221671 FDA 510(k)
FDA Product Code
GEI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The CellFX System is a Nanosecond Pulsed Field Ablation (nsPFA) Percutaneous Electrode System, designed for non-thermal cell ablation. This device leverages proprietary nanosecond pulse technology to selectively target and clear cells while preserving surrounding tissue integrity, primarily within the realm of plastic surgery applications. Its mechanism distinguishes it from traditional thermal ablation methods by delivering precise, non-thermal energy to achieve cellular disruption.

The CellFX System is intended for percutaneous use and is supplied as a reusable medical device. It is cleared by the FDA under 510(k) clearance (K221671) as substantially equivalent to existing devices in the General, Plastic Surgery category. The system is not classified as MRI-safe or MRI-conditional, and its sterility, single-use or reusable status is not explicitly detailed in the regulatory submission. Storage and handling instructions are not provided in the available data.

Frequently asked questions

What types of procedures is the CellFX System designed to assist with, and how does it differ from traditional ablation methods?

The CellFX System is designed for plastic surgery applications, specifically for non-thermal cell ablation. Unlike traditional thermal ablation methods—which rely on heat to destroy cells—it uses nanosecond pulsed field ablation (nsPFA) to selectively disrupt targeted cells while preserving surrounding tissue. This precision is particularly useful in procedures where minimizing collateral damage is critical.

Is the CellFX System intended for single-use or reusable applications, and how should it be handled?

The CellFX System is reusable, as explicitly stated in the manufacturer’s description. However, the regulatory submission does not provide specific details on sterility, cleaning protocols, or storage instructions. Clinicians should follow manufacturer guidelines (available from Pulse Biosciences, Inc.) to ensure proper handling and maintenance to maintain device integrity and safety.

What regulatory pathway was followed for FDA clearance, and what category does the CellFX System fall under?

The CellFX System received FDA 510(k) clearance (K221671) under the Traditional 510(k) Review pathway, determined to be substantially equivalent to existing devices in the General, Plastic Surgery category (product code: GEI). This clearance was granted by the Skin and Soft Tissue (SU) Advisory Committee on August 1, 2022.

Can the CellFX System be used in an MRI environment, and if not, what precautions should be taken?

The CellFX System is not classified as MRI-safe or MRI-conditional, meaning it should not be used in an MRI environment. If MRI imaging is required for the patient post-procedure, the device must be removed, and appropriate safety protocols for non-MRI-compatible devices should be followed to avoid interference or safety risks.

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. Sources consulted: Pulse Biosciences Announces First U.S. Procedure with the CellFX nsPFA ..., Investor Relations | Pulse Biosciences Inc., Pulse Biosciences - Powering the next generation in bioelectric ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pulse Biosciences, Inc.

Sources (1)

  • FDA 510(k) K221671 24 fields · synced Sep 20, 2026