Me HU-FG01721

GUDID 00806248007241

Home use, hand held, rechargeable blue light (414nm ) LED emitting device that is used for the treatment of mild to moderate inflammatory acne. This is a tester device.

Tanda Beauty Canada, Inc

Red/blue light phototherapy unit
Primary Device ID00806248007241
NIH Device Record Key9b092bd5-a8d4-4327-a919-0199a880f6ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameMe
Version Model NumberSeries 14
Catalog NumberHU-FG01721
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
GS100806248007241 [Primary]

FDA Product Code

OLPOver-The-Counter Powered Light Based Laser For Acne

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 Date2017-07-10

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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