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CellFX System

by Pulse Biosciences, Inc

510(k) K221671

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK221671 Date1 Aug 2022ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
GEI
FDA applicant
Pulse Biosciences, Inc.
Device class
Class II
Regulation
21 CFR Part 878.4400
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 20 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

From the manufacturer

HAYWARD, Calif. -- (BUSINESS WIRE)--May 9, 2024-- Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary CellFX® Nanosecond Pulsed Field Ablation™ (nsPFA™) technology, today announced the first procedure with the CellFX nsPFA Percutaneous Electrode System in the United States has been completed.

Source: investors.pulsebiosciences.com

Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients.

Source: investors.pulsebiosciences.com

Similar devices

Other devices filed under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

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