FDA.reportPublic FDA data

FotoFinder medicam

Primary DI
04260158450065
Brand
FotoFinder medicam
Company
FotoFinder Systems GmbH
Model
1000s
Device description
FotoFinder medicam is a video dermatoscope to take images of intact skin, scalp, hair and nail with high magnification and cross-polarized light. It is a non-invasive device for imaging and documentation only.
Published
2023-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IBJLight, Microscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IBJLight, MicroscopePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260158450065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260158450065042601584500654260158450065

GMDN Terms#

Term, Definition table
TermDefinition
Dermatoscope, digitalAn electrically-powered, hand-held instrument intended to be used for the microscopic examination of the external skin layers through the production of digital images (i.e. without direct optical view). The device has a built-in light source(s) and an electronic magnification system that provides the user with digital images of the structures of the epidermis and epidermal-dermal junction for visualization during dermatoscopy (also known as dermascopy). This device is commonly used for the examination of skin structures and to assess abnormal colour and pattern changes of pigmented skin lesions (e.g., spongy birth marks, malignant melanoma).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
342763695
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260158450089FotoFinder leviacamV12023-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00664816005866LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2025-10-20
00664816005873LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2025-10-20
00664816005934LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2025-10-20
00664816005941LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2025-10-20
00664816005958LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2025-10-20
00664816005965LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2025-10-20
08052691050002NED-DP Nano Eye Device for Digital PathologyNTP NANO TECH PROJECTS SRLIBJ2024-11-11
08052691050019NED-DH Nano Eye Device for Digital HematologyNTP NANO TECH PROJECTS SRLIBJ2024-11-11
GYNXMI60000GynexGYNEX CORPORATIONIBJ2023-12-20
04260158450089FotoFinder leviacamFotoFinder Systems GmbHIBJ2023-08-07
00664816002391LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2023-06-27
00664816002407LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2023-06-27
00664816002414LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2023-06-27
00664816002421LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2023-06-27
00664816002759LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2023-06-27
00852728008864SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDIBJ2023-03-02
00860009669192SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDIBJ2023-03-02
00860010027707SEILER MEDICAL DIVISIONSEILER INSTRUMENT AND MANUFACTURING COMPANY, INCORPORATEDIBJ2023-03-02
00850147000094MoleScope LiteMetaOptima Technology IncIBJ2023-02-17
85014700009486MoleScope LiteMetaOptima Technology IncIBJ2023-02-17
00304040043400Henry ScheinHENRY SCHEIN, INC.IBJ2022-05-03
00304040043417Henry ScheinHENRY SCHEIN, INC.IBJ2022-05-03
00304040043424Henry ScheinHENRY SCHEIN, INC.IBJ2022-05-03
00304040043431Henry ScheinHENRY SCHEIN, INC.IBJ2022-05-03
00304040043448Henry ScheinHENRY SCHEIN, INC.IBJ2022-05-03
00664816000908LW Scientific, IncLW SCIENTIFIC, INC.IBJ2021-04-09
00664816000922LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2021-04-09
00664816000939LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2021-04-09
00664816000946LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2021-04-09
00664816000953LW Scientific, Inc.LW SCIENTIFIC, INC.IBJ2021-04-09