FDA.reportPublic FDA data

INACTIVE - Skinlite II

Primary DI
00850017651678
Brand
INACTIVE - Skinlite II
Company
DermLite LLC
Model
SKL2
Catalog number
SKL2
Device description
INACTIVE - Skinlite II
Published
2024-06-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00850017651678PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017651678008500176516788500176516780850017651678

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

Contacts#

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

Regulatory Flags#

DUNS number
104621896
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true

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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