FDA.reportPublic FDA data

LUMIX ULTRA/PLUS

Primary DI
08057949171775
Brand
LUMIX ULTRA/PLUS
Company
FISIOLINE SRL
Model
LUMIX ULTRA 2
Catalog number
LULTRA33
Device description
LASER THERAPY UNIT LUMIX ULTRA/PLUS with 5 WAVELENGTH (650nm+810nm+910nm+980nm+1064nm)
Published
2023-06-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161198000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161198000Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.2016-07-26ILY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057949171775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057949171775080579491717758057949171775

GMDN Terms#

Term, Definition table
TermDefinition
Skin laser scannerAn electromechanical device intended to enable a laser beam, produced by an appropriate laser, to be scanned uniformly over a broad field of skin, typically for the removal of skin lesions (e.g., birthmarks, pigmentations) and tattoos. A laser beam is typically so intensely focused that only a tiny area can be treated at a time; large areas of skin must be treated using a scanner which sweeps the beam back and forth over the total target area.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Lumen/Inner Diameter20Millimeter
Lumen/Inner Diameter650Nanometer
Lumen/Inner Diameter810Nanometer
Lumen/Inner Diameter910Nanometer
Lumen/Inner Diameter980Nanometer
Lumen/Inner Diameter1064Nanometer

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity40 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Handling Environment Temperature40 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity40 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+390172470432fisioline@fisioline.com

Regulatory Flags#

DUNS number
338384498
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057949170280LUMIX CWLCW14022024-04-15
08057949171911LUMIXCPS2HPLUMIX CPSLUMIXCPS2HP2023-10-31
08057949170181LUMIX CWLCW2022023-06-14
08057949171560LUMIX ULTRA/PLUSLUMIX ULTRA 3LULTRA1902HP2023-06-14
08057949171577LUMIX ULTRA/PLUSLUMIX ULTRA 1LULTRA21HP2023-06-14
08057949171584LUMIX ULTRA/PLUSLUMIX ULTRA 1LULTRA35HP2023-06-14
08057949171591LUMIX ULTRA/PLUSLUMIX ULTRA 1LPLUS1001HP2023-06-14
08057949171607LUMIX ULTRA/PLUSLUMIX ULTRA 3LPLUS1002HP2023-06-14
08057949171614LUMIX ULTRA/PLUSLUMIX ULTRA 1LPLUS13HP2023-06-14
08057949171621LUMIX ULTRA/PLUSLUMIX ULTRA 2LPLUS1601HP2023-06-14
08057949171638LUMIX ULTRA/PLUSLUMIX ULTRA 3LPLUS1602HP2023-06-14
08057949171751LUMIX ULTRA/PLUSLUMIX ULTRA 2LPLUS302023-06-14
08057949171768LUMIX ULTRA/PLUSLUMIX ULTRA 2LPLUS30HP2023-06-14
08057949171782LUMIX ULTRA/PLUSLUMIX ULTRA 2LULTRA33HP2023-06-14
08057949171843LUMIX 100LUMIX 100 LUMIX100R32023-06-14
08057949171850LUMIX 250LUMIX 250 LUMIX250R32023-06-14
08057949171690LUMIX C.P.S.LUMIX C.P.S. 5LCPS292023-06-13
08057949171645LUMIX QLUMIX C.P.S. 3LUMIXQ012020-08-25
08057949171553LUMIX ULTRA/PLUSLUMIX ULTRA 2LULTRA1901HP2019-09-02
08057949170013LUMIX 2LUMIX 2L2PC012016-09-20

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Primary DI, Brand, Company table
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