FDA.reportPublic FDA data

Boston Aesthetics

Primary DI
06971782583392
Brand
Boston Aesthetics
Company
Shenzhen Peninsula Medical Group Co., Ltd.
Model
UV-X
Published
2026-05-07
Public version status
New
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K244022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K244022000308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)Boston Aesthetics, Inc.2025-03-13FTC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971782583392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971782583392069717825833926971782583392

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).

Regulatory Flags#

DUNS number
544317730
Device count
1
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06971782584252Boston AestheticsBoston Pico7552026-05-10
06971782584269Boston AestheticsBoston PICO2026-05-10
06971782583385Boston AestheticsUV-K2026-05-07
06971782583408Boston AestheticsUV-Y2026-05-07
06971782583415Boston AestheticsUV-Z2026-05-07
06971782586546Boston AestheticsPure+ B12026-05-07
06971782586553Boston AestheticsMicroRF 492026-05-07
06971782586560Boston AestheticsMicroRF 252026-05-07
06971782586577Boston AestheticsMicroRF 9N2026-05-07
06971782586584Boston AestheticsMicroRF 25N2026-05-07
06971782586591Boston AestheticsArtist D2.02026-05-07
06971782586607Boston AestheticsArtist D3.52026-05-07
06971782586614Boston AestheticsArtist D4.52026-05-07
06971782586621Boston AestheticsArtist D6.02026-05-07
06971782588137Boston AestheticsUnicorn+2026-05-07
06971782588144Boston AestheticsUnicorn+ I2026-05-07
06971782588151Boston Aesthetics Unicorn+ II2026-05-07
06971782588168Boston AestheticsUnicorn+ III2026-05-07
06971782588007Boston AestheticsUnicorn+2025-06-13
06971782588014Boston AestheticsUnicorn+ I2025-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971782583385Boston 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
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