GSD

Primary DI
06928258000877
Brand
GSD
Company
Shenzhen GSD Tech Co., Ltd.
Model
GP908D
Published
2024-09-30
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
FTCLight, Ultraviolet, Dermatological

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202827000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202827000308nm Excimer UV-light Skin Therapy SystemShenzhen Gsd Tech Co., Ltd.2020-12-15FTC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06928258000877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06928258000877069282580008776928258000877

GMDN Terms#

Term, Definition table
TermDefinition
Ultraviolet phototherapy unit, professionalA mains electricity (AC-powered) device with special lamps that emit ultraviolet B (UVB), or UVB and ultraviolet A (UVA) radiation intended to be used by a healthcare professional to treat a variety of dermatological disorders (e.g., psoriasis). The device is typically designed as a flat surface for lying with an overhead lamp(s), or as a chamber/cabinet, in which the patient stands, with interior walls lined with ultraviolet (UV) light tubes to allow full-body exposure and an even distribution of UV radiation. The device intended use may include psoralen + UVA therapy (oral administration of psoralen and subsequent exposure to UVA) (PUVA).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527221264
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06928258000846GSDGP900A82024-09-30
06928258000853GSDGP900Q82024-09-30
06928258000860GSDGP908B2024-09-30
06928258000884GSDGP900F2024-09-30
06928258000891GSDGP666C42024-09-30
06928258000907GSDGP900A2024-09-30
06928258000914GSDGP900Q2024-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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06928798600384KernelXuzhou Kernel Medical Equipment Co., Ltd.FTC2025-03-11
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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
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