PMA P230014S003

Device: Lumicell Direct Visualization System (DVS)
Applicant: Lumicell, Inc.
PMA number: P230014
Supplement: S003
Product code: SAW
Decision date: 2025-01-03
Classification: General, Plastic Surgery
Generic name: Fluorescence imaging for breast cancer detection
Approval order statement: Approval for a labeling update to add vaporized hydrogen peroxide cycles to the validated sterilization methods for reprocessing the Handheld Probe and Sterilization Tray used as part of the Lumicell DVS.

Current openFDA PMA Record#

Device: Lumicell Direct Visualization System (DVS)
Applicant: Lumicell, Inc.
PMA number: P230014
Supplement: S003
Product code: SAW
Generic name: Fluorescence imaging for breast cancer detection
Decision date: 2025-01-03
Decision code: APPR
Date received: 2024-11-14
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a labeling update to add vaporized hydrogen peroxide cycles to the validated sterilization methods for reprocessing the Handheld Probe and Sterilization Tray used as part of the Lumicell DVS.