FDA.reportPublic FDA data

Me

Primary DI
00806248007425
Brand
Me
Company
Tanda Beauty Canada, Inc
Model
Series 15
Catalog number
HU-FG01821
Device description
Home use, hand held, rechargeable red light (660nm ) LED emitting device that is used for the treatment of wrinkles, rhytides and fine lines in the periorbital region. This is a tester device.
Published
2017-07-10
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
OHSLight Based Over The Counter Wrinkle Reduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00806248007425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00806248007425008062480074258062480074250806248007425

GMDN Terms#

Term, Definition table
TermDefinition
Red/blue light phototherapy unitA portable electrically-powered device intended to emit both red and blue light for the treatment of a facial skin condition (e.g., acne, hyperpigmentation) by the patient in the home. It includes integral lights with a controller/controlling interface (to pair with an off-the-shelf computer/smartphone), and may be available in a variety of forms (e.g., a face-worn light mask with controller, hand-held light unit). It is not intended for use with a photosensitizing agent. This is a single-patient, reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
248047115
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00806248005322IluminageHU-FG00851USHU-FG00851US2016-10-19
00806248006336IluminageHU-CO00621HU-CO006212016-10-19
10806248005329IluminageHU-FG00851USHU-FG00851US2016-10-19
10806248006333IluminageHU-CO00621HU-CO006212016-10-19
00806248007296IluminageHU-FG017512017-07-10
00806248004936TandaSeries 4HU-FG006312017-10-02
00806248005186TandaSeries 4HU-FG009612017-10-02
00806248004929TandaSeries 4HU-FG006212017-10-02
20806248004930TandaSeries 4HU-FG006312017-10-02
20806248005180TandaSeries 4HU-FG009612017-10-02
00806248006114MeSeries 14HU-FG012712016-09-24
00806248007555MeSeries 14HU-FG018712017-08-23
20806248006118MeSeries 14HU-FG012712016-09-24
00806248006459MeSeries 15HU-FG012812016-09-24
00806248007241MeSeries 14HU-FG017212017-07-10
00806248007289MeSeries 14HU-CO008212017-07-25
00806248007432MeSeries 14HU-CO008712017-07-11
00806248007463MeSeries 15HU-CO009012017-07-11
20806248007559MeSeries 14HU-FG018712017-08-23
00806248007562MeSeries 15HU-FG018812017-08-23

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