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Lumicell Direct Visualization System (DVS) 810-00217

by Lumicell, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860003252543 UDI-DI Date19 Nov 2024ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 — GUDID listing Listed

Specification

GUDID

Trade Name
Lumicell Direct Visualization System (DVS)
Generic Name
Intraoperative tumour margin fluorescence imaging system
Model / Reference
810-00217
Primary DI / UDI-DI
00860003252543
PMA Number
FDA Product Code
SAW
GMDN Term
Intraoperative tumour margin fluorescence imaging system
Device Class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Intraoperative tumour margin fluorescence imaging system

Cleared under the same submission (P230014)

Other devices from Lumicell, Inc.

Properties

  • Prescription Use
  • Combination Product
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No