LEP 2000 Photonic Therapy System

GUDID B420LEP2000PTS0

IMI Healing Technologies Inc

Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp Blue/red/infrared phototherapy lamp
Primary Device IDB420LEP2000PTS0
NIH Device Record Keya7414e0d-f74c-443b-a1e1-f397ec2a5117
Commercial Distribution StatusIn Commercial Distribution
Brand NameLEP 2000 Photonic Therapy System
Version Model Number1
Company DUNS248483948
Company NameIMI Healing Technologies Inc
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
HIBCCB420LEP2000PTS0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHNPowered Light Based Non-Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-22

On-Brand Devices [LEP 2000 Photonic Therapy System]

B420LEP2000PTS01
B420LEP2000100D0LEP2000100D
B420LEP2000100C0LEP2000100C
B420LEP2000100B0LEP2000100B
B420LEP2000100A0LEP2000100A
B420LD1000LD100
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.