GigaLaser GL1801 RB

GUDID 57135920222503

Powermedic ApS

Musculoskeletal/physical therapy laser, professional
Primary Device ID57135920222503
NIH Device Record Keyc131a802-a41b-4081-b3f8-4fd3d96a0a4c
Commercial Distribution StatusIn Commercial Distribution
Brand NameGigaLaser GL1801 RB
Version Model Number22250
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
GS105713592022255 [Previous]
GS157135920222503 [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 Date2023-06-22
Device Publish Date2023-06-14

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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.