FDA.reportPublic FDA data

Spectroline

Primary DI
00672052155344
Brand
Spectroline
Company
SPECTRONICS CORPORATION
Model
Q-22
Catalog number
102
Device description
Two 4-Watt Integrally Filtered UV-A Tubes and Two 4-Watt White Light Tube. Woods Lamps. These lamps feature an extra-lightweight ballast and housing design, for fatigue-free use. Rugged fixed handles and heavy-duty power cords with strain reliefs ensure added durability.
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FTCLight, Ultraviolet, Dermatological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTCLight, Ultraviolet, DermatologicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00672052155344PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00672052155344006720521553446720521553440672052155344

GMDN Terms#

Term, Definition table
TermDefinition
Wood's lampA light designed to emit ultraviolet light (at a wavelength of approximately 365 nm) to illuminate parts of the body to observe fluorescence for diagnostic purposes. It is typically used to help diagnose dermal fungal infections (e.g., Microsporum audouini), bacterial infections (e.g., Corynebacterium minutissimum, Pseudomonas), parasitic infections (e.g., scabies), and pigmentary disorders (e.g., vitiligo). It also often used to examine rape victims for sperm residues or examine a patient's eyes for corneal lesions.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002044410
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00672052155276SpectrolineQ-121022016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971782583385Boston AestheticsShenzhen Peninsula Medical Group Co., Ltd.FTC2026-05-07
06971782583392Boston AestheticsShenzhen Peninsula Medical Group Co., Ltd.FTC2026-05-07
06971782583408Boston AestheticsShenzhen Peninsula Medical Group Co., Ltd.FTC2026-05-07
06971782583415Boston AestheticsShenzhen Peninsula Medical Group Co., Ltd.FTC2026-05-07
06946725599990APKAPK Technology Co.,Ltd.FTC2025-09-22
B219E780MUVBNB0Solarc/SolRx E-SeriesSolarc Systems IncFTC2025-04-01
B219E790MUVBNB0Solarc/SolRx E-SeriesSolarc Systems IncFTC2025-04-01
06928798600377KernelXuzhou Kernel Medical Equipment Co., Ltd.FTC2025-03-11
06928798600384KernelXuzhou Kernel Medical Equipment Co., Ltd.FTC2025-03-11
06928798600391KernelXuzhou Kernel Medical Equipment Co., Ltd.FTC2025-03-11
06928798600421KernelXuzhou Kernel Medical Equipment Co., Ltd.FTC2025-03-11
06928798600438KernelXuzhou Kernel Medical Equipment Co., Ltd.FTC2025-03-11
06928798600445KernelXuzhou Kernel Medical Equipment Co., Ltd.FTC2025-03-11
06928798600452KernelXuzhou Kernel Medical Equipment Co., Ltd.FTC2025-03-11
00810182930930DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-13
00810182930008DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930015DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930022DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930039DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930046DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930053DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930060DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930077DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930084DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930091DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930107DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930114DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930121DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930138DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12
00810182930145DAAVLINDAAVLIN DISTRIBUTING CO., THEFTC2024-12-12