LED Daylite REVEAL

Basic Information

• Brand Name: LED Daylite REVEAL
• Primary DI: 00810070572600
• Version / Model: 9500-0000-0000
• Company Name: Designs For Vision, Inc.
• Labeler DUNS: 001335819
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-24
• Public Version: 1
• Public Version Date: 2025-07-02
• Public Version Status: New
• Public Device Record Key: 4937dea9-03db-485d-ba73-5659ffce11c0

Device Description

The REVEAL FC is indicated for use as a wound autofluorescence imaging device to view autofluorescence images from skin wounds that are exposed to its excitation light.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QCR	Wound Autofluorescence Imaging Device	General, Plastic Surgery	878.4165	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63176	Fluorescence wound imaging unit	A hand-held, electrically-powered device designed to use violet light illumination and imaging to visualize fluorescent bacteria within/around a wound to assist with wound care protocols and documentation. It includes a violet light(s) for wound illumination and fluorescence, lens, display screen, and includes video/image capture technology.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810070572600	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]