FOTONMEDIX

GUDID 06976487170090

Infrared and near infrared phototherapy device emitting up to 30 W at 810nm, 915nm, 940nm, 980nm, 650nm, 10.1 Inch LCD Touch Screen display

Fotonmedix Medical Laser Co., LTD

Musculoskeletal/physical therapy laser, professional
Primary Device ID06976487170090
NIH Device Record Keyaf4c2e55-d473-4b89-adb0-0647c97d572d
Commercial Distribution StatusIn Commercial Distribution
Brand NameFOTONMEDIX
Version Model NumberLaserMedix3000U5
Company DUNS602442900
Company NameFotonmedix Medical Laser Co., LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106976487170090 [Primary]

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 Date2025-02-10
Device Publish Date2025-02-01

On-Brand Devices [FOTONMEDIX]

06976487170007Near Infrared phototherapy device emitting up to 45 W at 980 nm, 12.1 Inch LCD Touch Screen disp
06976487170090Infrared and near infrared phototherapy device emitting up to 30 W at 810nm, 915nm, 940nm, 980n

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