Skip to content

Lumicell Direct Visualization System (DVS)

by Lumicell, Inc.

PMA P230014

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

PMA P230014↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP230014 Date17 Apr 2024ApprovedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2519-2025 FDA Class II initiated 31 Jul 2025

    The potential of the elastic bands included in the kit detaching or fracturing during surgical procedures. As a result, these failures may pose a risk of retained foreign bodies in the surgical cavity and potentially leading to surgical site infections.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Generic Name
Fluorescence imaging for breast cancer detection
PMA Number
FDA Product Code
SAW
Device Class
Class III
Advisory Committee
General, Plastic Surgery
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 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 Lumicell Direct Visualization System (DVS) is a fluorescence imaging system classified as a Class III device under FDA regulations. It is designed for intraoperative use in adults undergoing lumpectomy for breast cancer, providing adjunctive detection of residual cancerous tissue within the resection cavity through fluorescence imaging.

The system is used in the operating room with the optical imaging agent LUMISIGHT (pegulicianine) for injection. It is a single-use, non-sterile device (unless sterilised by the user) and requires no specific MRI safety considerations. Approved under PMA P230014, it is supplied as a complete imaging unit with associated software and imaging probes, adhering to FDA-mandated premarket approval standards for surgical adjuncts.

Other devices from Lumicell, Inc.

Questions

AI-generated answers, 18 Sep 2026

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

  • What is the Lumicell Direct Visualization System (DVS) primarily used for in the operating room?

    The Lumicell Direct Visualization System (DVS) is designed as an intraoperative adjunct to help surgeons detect residual cancerous tissue in the resection cavity during lumpectomy procedures for adult breast cancer patients. It uses fluorescence imaging with the optical agent LUMISIGHT (pegulicianine) to visualize cancerous areas that may remain after the primary tumor is removed.

  • Is the Lumicell Direct Visualization System (DVS) single-use or reusable, and does it require sterilization?

    The Lumicell Direct Visualization System (DVS) is classified as a single-use device, though it can be sterilized by the user if needed. This means each system is intended for one surgical procedure unless reprocessed according to manufacturer guidelines. Sterilization is not required by default, but it may be performed to extend its use.

  • What types of imaging probes and software are included with the Lumicell Direct Visualization System (DVS)?

    The Lumicell Direct Visualization System (DVS) is supplied as a complete imaging unit, which includes the necessary imaging probes and associated software for fluorescence imaging. These components work together to enable real-time visualization of cancerous tissue during surgery, ensuring the system is ready for immediate intraoperative use.

  • How was the Lumicell Direct Visualization System (DVS) approved by the FDA, and what regulatory pathway was followed?

    The Lumicell Direct Visualization System (DVS) was approved under the FDA’s Premarket Approval (PMA) pathway, specifically under PMA number P230014. This classification reflects its status as a Class III device, requiring rigorous review to demonstrate safety and effectiveness for its intended use as an adjunct in breast cancer surgery. The approval was granted on April 17, 2024.

  • Does the Lumicell Direct Visualization System (DVS) require any special considerations for use in the operating room, such as MRI safety?

    The Lumicell Direct Visualization System (DVS) does not have any specific MRI safety considerations, meaning it can be safely used in the operating room without interference or restrictions related to MRI environments. Its design focuses solely on fluorescence imaging for intraoperative cancer detection.