FDA.reportPublic FDA data

DermLite Skeen

Primary DI
08500176518382
Brand
DermLite Skeen
Company
DermLite LLC
Model
SK2
Catalog number
SK2
Device description
Handheld Dermatoscope. Dermatoscopes provide a noninvasive technique to visually aid the doctor in the early diagnosis of pigmented skin lesions and malignant melanoma. These devices allow magnified visualization of pigmented lesions beyond what would be visible to the physician with a naked eye.
Published
2026-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

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
08500176518382PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08500176518382085001765183828500176518382

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).

Contacts#

Phone, Email table
PhoneEmail
949-481-6384p.wojtaszek@dermlite.com

Regulatory Flags#

DUNS number
104621896
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850017651739DermLite DL5 PlusDL5PDL5P2024-06-20
00850017651012DL2 Silicone SleeveDLIISSDLIISS2024-06-20
00850017651029MagnetiConnect for all phone/tablet adaptersDLMCDLMC2024-06-20
00850017651036MagnetiConnect Adapter - 37 mmDLMC-37DLMC-372024-06-20
00850017651043MagnetiConnect Adapter - 52 mmDLMC-52DLMC-522024-06-20
00850017651067MagnetiConnect for Nikon 1 AW1DLMC-N1DLMC-N12024-06-20
00850017651074DL200/Lumio S Drawstring PouchDSPDSP2024-06-20
00850017651081FOTO Cable (Head to PowerPack)FOTO-CABLEFOTO-CABLE2024-06-20
00850017651098PowerPack ChargerFOTO-CHARGERFOTO-CHARGER2024-06-20
00850017651104DermLite GL BatteryGLBGLB2024-06-20
00850017651111IceCap for DL200, 100-packICDL200-100ICDL200-1002024-06-20
00850017651128IceCap for DL4 & Foto X, 100-packICDL4-100ICDL4-1002024-06-20
00850017651135IceCap Covers for Nailio, 50-packICNL1-50ICNL1-502024-06-20
00850017651142DL4/DL200 USB CableMUSBMUSB2024-06-20
00850017651159Foto X/GL USB-C CableMUSB-CMUSB-C2024-06-20
00850017651166Lumio 2 BatteryDLU2BDLU2B2024-06-20
00850017651173Lumio 2 +2.5x Lens AccessoryDLU2-1240DLU2-12402024-06-20
00850017651180Lumio 2 495nm Longpass FilterDLU2-1230DLU2-12302024-06-20
00850017651197DL handyscope Faceplate - blankFFH2-1238FFH2-12382024-06-20
00850017651203DL handyscope Faceplate - markedFFH2-1240FFH2-12402024-06-20

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