LED Helmet

GUDID 05060494130589

S2185 LED Helmet

THOR PHOTOMEDICINE LIMITED

Red-light phototherapy unit
Primary Device ID05060494130589
NIH Device Record Key0eb47790-70bc-462c-b1fb-fe58bf1fb014
Commercial Distribution StatusIn Commercial Distribution
Brand NameLED Helmet
Version Model Number2.3
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
GS105060494130589 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-14
Device Publish Date2021-10-06

Devices Manufactured by THOR PHOTOMEDICINE LIMITED

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05060494130640 - 19 LED Cluster issue 32025-08-08 S2131 19 LED Cluster issue 3
05060494130657 - 104 LED Cluster issue 32025-08-08 S2140 104 LED Cluster issue 3
05060494130619 - 810nm 200mW NIR Light Guide Laser2025-07-23 S2091 810nm 200mW NIR Light Guide Laser
05060494130626 - 660nm 75mW Red Light Guide Laser2025-07-23 S2173 660nm 75mW Red Light Guide Laser
05060494130589 - LED Helmet2021-10-14S2185 LED Helmet
05060494130589 - LED Helmet2021-10-14 S2185 LED Helmet
05060494130596 - LED Helmet PRX2021-10-14 S2194 LED Helmet PRX
05060494130572 - LED Lollipop2021-10-11 S2197 LED Lollipop
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