FDA.reportPublic FDA data

Me

Primary DI
20806248007559
Brand
Me
Company
Tanda Beauty Canada, Inc
Model
Series 14
Catalog number
HU-FG01871
Device description
Home use, hand held, rechargeable blue light (414nm ) LED emitting device that is used for the treatment of mild to moderate inflammatory acne.
Published
2017-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
OLPOver-The-Counter Powered Light Based Laser For Acne

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLPOver-The-Counter Powered Light Based Laser For AcneGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10806248007552PackageGS16In Commercial Distribution
20806248007559PackageGS14In Commercial Distribution
00806248007555PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1080624800755210806248007552
2080624800755920806248007559
00806248007555008062480075558062480075550806248007555

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00806248007425MeSeries 15HU-FG018212017-07-10
00806248007432MeSeries 14HU-CO008712017-07-11
00806248007463MeSeries 15HU-CO009012017-07-11
00806248007562MeSeries 15HU-FG018812017-08-23

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