FDA.reportPublic FDA data

EXCI308 by Aerolase

Primary DI
03760313461017
Brand
EXCI308 by Aerolase
Company
CLARTEIS
Model
EIPL-100
Catalog number
EIPL-PRD-K01-exci308
Device description
Exci308® by AerolaseThis medical device is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma.Excimer light source, wavelength 308nm, optical power 2500 mW.
Published
2022-06-13
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
K191086000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191086000ExciplexClarteis2019-12-11FTC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03760313461017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760313461017037603134610173760313461017

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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
266012441
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760313461000Exciplex®EIPL-100EIPL-PRD-K01-(US)2020-09-09

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
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