69 LED Cluster Probe 660nm & 850nm 1390mW

GUDID 05060494130121

S1110 69 LED Cluster Probe 660nm & 850nm 1390mW

THOR PHOTOMEDICINE LIMITED

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Primary Device ID05060494130121
NIH Device Record Keyc2274473-e016-4ae9-a963-92f5dcea6f5b
Commercial Distribution StatusIn Commercial Distribution
Brand Name69 LED Cluster Probe 660nm & 850nm 1390mW
Version Model Number2.0
Company DUNS856233908
Company NameTHOR PHOTOMEDICINE LIMITED
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105060494130121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ILYLamp, Infrared, Therapeutic Heating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-20

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05060494130503 - NovoTHOR2021-01-18 S2188 NovoTHOR
05060494130510 - NovoTHOR XL2021-01-18 S2190 NovoTHOR XL

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