PowerLaser Pro500

GUDID 05713592021166

Powermedic ApS

Musculoskeletal/physical therapy laser, home-use
Primary Device ID05713592021166
NIH Device Record Key6e33211f-a564-4791-b92c-9346780ac66a
Commercial Distribution StatusIn Commercial Distribution
Brand NamePowerLaser Pro500
Version Model Number2116
Company DUNS305378978
Company NamePowermedic ApS
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 Datefalse
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
GS105713592021166 [Primary]

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 Date2019-01-08
Device Publish Date2016-11-22

Devices Manufactured by Powermedic ApS

05713592301824 - PowerLaser Basic1800 Vet Cool Grey2024-04-03
05713592301831 - PowerLaser Basic1800 Vet Olive Green2024-04-03
05713592301848 - PowerLaser Basic1800 Vet Platinum2024-04-03
05713592400558 - PowerLaser Pro500 VET Red2023-10-24
05713592401555 - PowerLaser Pro1500 VET Red2023-10-24
05713592451215 - PowerLaser Pro1200 Black2023-10-24
05713592451253 - PowerLaser Pro1200 Red2023-10-24
05713592500104 - PowerLaser Pro1200 White2023-10-24

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