FDA.reportPublic FDA data

Firefly

Primary DI
00851289007309
Brand
Firefly
Company
Firefly Global
Model
DE308
Device description
Digital Dermatoscope
Published
2024-10-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KYTLight, Examination, Medical, Battery Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYTLight, Examination, Medical, Battery PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851289007309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851289007309008512890073098512890073090851289007309

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
020089936
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851289007347FireflyDE6082025-07-18
00851289007354FireflyES201M2025-07-18
00851289007316FireflyDE334T2024-10-24
00851289007323FireflyDE4082024-10-24
00851289007330Firefly DE5082024-10-24
00851289007293FireflyES6152024-07-01
00851289007286Firefly GlobalES1202023-10-16
00851289007279FireflyES10342023-10-13
00851289007231Firefly GlobalES10402022-12-06
00851289007224Firefly DE12702022-09-20
00851289007217Firefly GlobalES20402022-08-31
00851289007002FireflyES2012016-09-24
00851289007101Firefly DE5702020-02-13
00851289007125Firefly ES1002020-02-13
00851289007132Firefly ES1032020-02-13
00851289007149Firefly ES1042020-02-13
00851289007156FireflyES1052020-02-13
00851289007163FireflyES1502020-02-13
00851289007170Firefly ES1602020-02-13
00851289007187FireflyDE337T2020-02-13

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00714646001375Rechargeable Light SourceBionix, LLCKYT2025-02-25
07290016672756TytoProTYTO CARE LTDKYT2024-05-26
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