DermoSight Dermatoscope

Primary DI
00860013961404
Brand
DermoSight Dermatoscope
Company
DEEPX HEALTH, LLC
Model
DXH-HW-100
Catalog number
DXH-HW-100
Device description
Handheld optical skin imaging device
Published
2025-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
PSNLight Based Imaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PSNLight Based ImagingGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860013961404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860013961404008600139614048600139614040860013961404

GMDN Terms#

Term, Definition table
TermDefinition
Dermatoscope, opticalAn electrically-powered, hand-held instrument intended to be used for the direct microscopic examination of the external skin layers. The device has a built-in light source and magnification system that provides the user with the visualization of the structures of the epidermis and epidermal-dermal junction during dermatoscopy (also known as dermascopy). Oil may be applied to the skin to enhance skin transparency. 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
118742338
Device count
1
Combination product
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860013961411DermoSight SoftwareDXH-SW-100DXH-SW-1002025-06-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013961411DermoSight SoftwareDEEPX HEALTH, LLCPSN2025-06-19
08602920003066VivaScope SystemCaliber Imaging & Diagnostics, Inc.PSN2023-02-16
05415334036192DemetraBarco NVPSN2021-06-28
05415334001763DemetraBarco NVPSN2020-06-04
00628451918035MoleMateMedX Health CorpPSN2016-09-22
00628451918004MoleMateMedX Health CorpPSN2016-09-22
00628451918073SIMSYSMedX Health CorpPSN2016-09-22
00860292000306VivaScope SystemCaliber Imaging & Diagnostics, Inc.PSN2016-08-22