PMA P230014S004

Device: Lumicell Direct Visualization System (DVS)
Applicant: Lumicell, Inc.
PMA number: P230014
Supplement: S004
Product code: SAW
Decision date: 2025-11-25
Classification: General, Plastic Surgery
Generic name: Fluorescence imaging for breast cancer detection
Approval order statement: Approval for changes to the labeling including additional caution/warning/guidance statements and updated labeling to address corrective actions taken with respect to breaking or detachment of elastic bands from the device during use.

Current openFDA PMA Record#

Device: Lumicell Direct Visualization System (DVS)
Applicant: Lumicell, Inc.
PMA number: P230014
Supplement: S004
Product code: SAW
Generic name: Fluorescence imaging for breast cancer detection
Decision date: 2025-11-25
Decision code: APPR
Date received: 2025-11-10
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for changes to the labeling including additional caution/warning/guidance statements and updated labeling to address corrective actions taken with respect to breaking or detachment of elastic bands from the device during use.