FDA.reportPublic FDA data

LED Daylite REVEAL

Primary DI
00810070572600
Brand
LED Daylite REVEAL
Company
Designs For Vision, Inc.
Model
9500-0000-0000
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.
Published
2025-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QCRWound Autofluorescence Imaging Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QCRWound Autofluorescence Imaging DeviceGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810070572600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810070572600008100705726008100705726000810070572600

GMDN Terms#

Term, Definition table
TermDefinition
Fluorescence wound imaging unitA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1(631)585-3300glevites@dvimail.com

Regulatory Flags#

DUNS number
001335819
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00627987231151Ray 1Swift Medical IncQCR2022-04-18