FDA.reportPublic FDA data

Me

Primary DI
10806248006951
Brand
Me
Company
ILUMINAGE LTD
Model
HU-CO00771
Device description
Over-the counter home use device that is intended for the removal of unwanted hair.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONFPowered Light Based Non-Laser Surgical Instrument With Thermal EffectGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20806248006958PackageGS13In Commercial Distribution
10806248006951PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080624800695820806248006958
1080624800695110806248006951

GMDN Terms#

Term, Definition table
TermDefinition
Cosmetic red-light phototherapy system, home-useAn assembly of mains electricity (AC-powered) devices designed to emit low-level broad-band (LLBB) red light in the visible and invisible spectra together with heat [light and heat energy (LHE)] for the cosmetic treatment of dermatological conditions in the home. It typically consists of an energy generator and an attached applicator to apply the energy to the skin. It is designed to be operated by the patient typically for self body hair removal, skin rejuvenation, vascular and pigmented lesion removal, wrinkle reduction, collagen renewal, acne clearance, and/or mild to moderate psoriasis care.

Regulatory Flags#

DUNS number
533309022
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10806248004438MeHU-FG00501US2016-09-24
10806248004490Iluminage FG70701US-Q2016-09-24
10806248005312MeHU-CO003412016-09-24
10806248005589IluminageHU-FG01171US2016-09-24
10806248005831Iluminage HU-CO005412016-09-24
10806248005848MeHU-FG00691NA2016-09-24
10806248006074MeHU-FG00501NA2016-09-24
10806248006180MeHU-FG00691WL2016-09-24
10806248006678IluminageHU-FG01171VC2016-09-24
10806248006906MeHU-CO007212016-09-24
20806248004435MeHU-FG00501US2016-09-24
20806248004497Iluminage FG70701US-Q2016-09-24
20806248005319MeHU-CO003412016-09-24
20806248005586IluminageHU-FG01171US2016-09-24
20806248005838Iluminage HU-CO005412016-09-24
20806248005845MeHU-FG00691NA2016-09-24
20806248006071MeHU-FG00501NA2016-09-24
20806248006187MeHU-FG00691WL2016-09-24
20806248006675IluminageHU-FG01171VC2016-09-24
10806248006685IluminageFG70701US-S2016-09-24

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Primary DI, Brand, Company table
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00860015460622NextGen Aesthetics IPLT AESTHETICS LLCONF2026-03-12
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00860009525146MediLightMEDICREATIONS LLCONF2026-02-11
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08057622080004MTONE EVOM & T SRLONF2025-04-15
08057622080011MTONE EVOM & T SRLONF2025-04-15
08057622080028MT ONEM & T SRLONF2025-04-15
08057622080035MT ONEM & T SRLONF2025-04-15
08057622080042MT ONE DIAMONDM & T SRLONF2025-04-15
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