Me HU-CO00901

GUDID 00806248007463

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 store display.

Tanda Beauty Canada, Inc

Red/blue light phototherapy unit
Primary Device ID00806248007463
NIH Device Record Key9807044f-d262-4159-a365-fdf7a8b950e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameMe
Version Model NumberSeries 15
Catalog NumberHU-CO00901
Company DUNS248047115
Company NameTanda Beauty Canada, Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100806248006770 [Direct Marking]
GS100806248007463 [Primary]

FDA Product Code

OHSLight Based Over The Counter Wrinkle Reduction

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-07-11

On-Brand Devices [Me]

00806248007562Home use, hand held, rechargeable red light (660nm ) LED emitting device that is used for the tr
20806248007559Home use, hand held, rechargeable blue light (414nm ) LED emitting device that is used for the t
00806248007463Home use, hand held, rechargeable red light (660nm ) LED emitting device that is used for the tr
00806248007432Home use, hand held, rechargeable blue light (414nm ) LED emitting device that is used for the t
00806248007425Home use, hand held, rechargeable red light (660nm ) LED emitting device that is used for the tr
00806248007289Home use, hand held, rechargeable blue light (414nm ) LED emitting device that is used for the t
00806248007241Home use, hand held, rechargeable blue light (414nm ) LED emitting device that is used for the t
00806248006459Home use, hand held, rechargeable red light (660nm ) LED emitting device that is used for the tr
20806248006118Home use, hand held, rechargeable blue light (414nm ) LED emitting device that is used for the t

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