FDA.reportPublic FDA data

ExSys 308

Primary DI
B12510000
Brand
ExSys 308
Company
GME German Medical Engineering GmbH
Model
1000
Catalog number
1000
Device description
Excimer light 308 nm system
Published
2018-04-16
Public version status
Update
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
K150752000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150752000GME ExSys 308Gme (German Medical Engineering) GmbH2015-07-31FTC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B12510000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological excimer laser systemA mains electricity (AC-powered) device assembly in which input energy is used to excite an excimer gas to emit a high-power ultraviolet laser beam (UVA and/or UVB) intended for dermal phototherapy. It typically includes a light source, delivery/positioning device(s), and controls/foot-switch. It is typically intended to treat disorders such as psoriasis, vitiligo, atopic dermatitis, and leukoderma.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity0 Percent (%) Relative Humidity89 Percent (%) Relative Humidity
Handling Environment Temperature18 Degrees Celsius30 Degrees Celsius
Storage Environment Humidity0 Percent (%) Relative Humidity99 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
342234451
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B12510700FlexSys107010702021-03-10
B12510600TwinScan 808/755 Laser System106010602019-11-29
B12510420C + B Pelo104210422018-04-16
B12510500LinScan105010502018-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971782583385Boston AestheticsShenzhen Peninsula Medical Group Co., Ltd.FTC2026-05-07
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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
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
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