PowerLaser Basic 1200 Olive Green

GUDID 57135920351234

Powermedic ApS

Musculoskeletal/physical therapy laser, home-use
Primary Device ID57135920351234
NIH Device Record Key87b5054c-f091-454c-a487-b440bb4c60dd
Commercial Distribution StatusIn Commercial Distribution
Brand NamePowerLaser Basic 1200 Olive Green
Version Model Number35123
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
GS105713592030120 [Previous]
GS157135920351234 [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 Date2023-06-21
Device Publish Date2023-06-13

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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