FDA.reportPublic FDA data

DAAVLIN

Primary DI
00810182930985
Brand
DAAVLIN
Company
DAAVLIN DISTRIBUTING CO., THE
Model
Phothera Pro HF
Device description
PPHF NBUVB 10L MM
Published
2024-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K220840000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K2208400001 Series Phototherapy EquipmentDaavlin Distributing Co.2022-04-22FTC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810182930985PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810182930985008101829309858101829309850810182930985

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)322-8546info@daavlin.com

Regulatory Flags#

DUNS number
056696347
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810182930299DAAVLINPhothera 6002024-12-12
00810182930305DAAVLINPhothera 600-3D2024-12-12
00810182930312DAAVLINPhothera 600-3D2024-12-12
00810182930329DAAVLINPhothera 600-3D2024-12-12
00810182930336DAAVLINPhothera 600-3D2024-12-12
00810182930343DAAVLINPhothera 600-3D2024-12-12
00810182930350DAAVLINPhothera 600-3D2024-12-12
00810182930367DAAVLINPhothera 600-3D2024-12-12
00810182930374DAAVLINPhothera 600-3D2024-12-12
00810182930381DAAVLINPhothera 600-3D2024-12-12
00810182930398DAAVLINPhothera 600-3D2024-12-12
00810182930404DAAVLINPhothera 600-3D2024-12-12
00810182930411DAAVLINPhothera 600-3D2024-12-12
00810182930602DAAVLINPhothera Pro 600-3D2024-12-12
00810182930619DAAVLINPhothera Pro 600-3D2024-12-12
00810182930626DAAVLINPhothera Pro 600-3D2024-12-12
00810182930633DAAVLINPhothera Pro 600-3D2024-12-12
00810182930640DAAVLINPhothera Pro 600-3D2024-12-12
B2809808HO0004CT5DAAVLIN7 Series2024-12-12
B2809808HO0004CT6DAAVLIN7 Series2024-12-12

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