FDA.reportPublic FDA data

MY MASK-E

Primary DI
08056389700392
Brand
MY MASK-E
Company
ESPANSIONE MARKETING SPA
Model
MY MASK-E/M500
Catalog number
MY MASK-E/M500
Published
2020-05-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IRTPad, Heating, PoweredPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08056389700392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08056389700392080563897003928056389700392

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment systemA mains electricity (AC-powered) mobile (on wheels) assembly of devices that uses multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, and radio-frequency (RF) energy] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes a lamp(s) and additional energy sources (typically a laser(s), and/or a RF generator); dedicated applicators (handpieces) intended to apply the different energies to the skin are also included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
339474539
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056389701115YOUNG AGAINYOUNG AGAIN2026-04-30
08056389701122EPI-C PLUSEPI-C PLUSEPI-C PLUS2026-04-30
08056389700194E-LIGHT LINEMASK LM YELLOW/CEMASK LM YELLOW/CE2018-06-06
08056389700019E-LIGHT LINEE-LIGHT DEVICEE-LIGHT DEVICE2019-11-21
08056389700095E-LIGHT LINELED MASKH-20LED MASK H-202019-09-03
08056389700118E-LIGHT LINELED MASKLED MASK2018-06-06
08056389700132E-LIGHT LINELED MASK/RED-05LED MASK/RED-052018-06-06
08056389700156E-LIGHT LINELED MASK/RED-20LED MASK/RED-202018-06-06
08056389700170E-LIGHT LINEMASK LM RED/CEMASK LM RED/CE2018-06-06
08056389700187E-LIGHT LINEMASK LM BLUE/CEMASK LM BLUE/CE2018-06-06
08056389700378MY MASK-EMY MASK-E/PSMY MASK-E/PS2020-05-25
08056389700385MY MASK-EMY MASK-E/M250MY MASK-E/M2502020-05-25
08056389700408MY MASK-EMY MASK-E/M2000MY MASK-E/M20002020-05-25
08056389700217E-LIGHT LINELED MASK/BLUE-05LED MASK/BLUE-052019-05-24
08056389701009E-LIGHT LINEIPL LAMP-390 IPL LAMP-3902024-05-14
08056389701016E-LIGHT LINEIPL LAMP-550 IPL LAMP-5502024-05-14
08056389701023E-LIGHT LINEIPL LAMP-LSIPL LAMP-LS2024-05-14
08056389701030E-LIGHT LINEIPL LAMP-DSIPL LAMP-DS2024-05-14
08056389701047E-LIGHT LINEEPI-C PLUSEPI-C PLUS2024-05-14
08056389701351E-LIGHT LINEMASK LM RED/CE-0500MASK LM RED/CE-05002023-04-11

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