PMA P230014S002

Device: Lumicell Direct Visualization System
Applicant: Lumicell, Inc.
PMA number: P230014
Supplement: S002
Product code: SAW
Decision date: 2024-11-26
Classification: General, Plastic Surgery
Generic name: Fluorescence imaging for breast cancer detection
Approval order statement: Approval for the addition of a trim-potentiometer to the electrical circuit of the light source and addition of a component-level power specification.

Current openFDA PMA Record#

Device: Lumicell Direct Visualization System
Applicant: Lumicell, Inc.
PMA number: P230014
Supplement: S002
Product code: SAW
Generic name: Fluorescence imaging for breast cancer detection
Decision date: 2024-11-26
Decision code: APPR
Date received: 2024-09-17
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the addition of a trim-potentiometer to the electrical circuit of the light source and addition of a component-level power specification.