OrthoPulse OPi2S-100

GUDID 09120118090067

Biolux Technology GmbH

Red-light phototherapy unit
Primary Device ID09120118090067
NIH Device Record Keyccabc343-4a5e-4e58-b30d-84162d9279fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameOrthoPulse
Version Model NumberOrthoPulse 2.0 Standard
Catalog NumberOPi2S-100
Company DUNS300613819
Company NameBiolux Technology GmbH
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 Datetrue
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
GS109120118090067 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PLHOrthodontic Led Accessory

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-25
Device Publish Date2022-07-16

On-Brand Devices [OrthoPulse]

09120118090029OPi
09120118090067OrthoPulse 2.0 Standard
09120118090074OrthoPulse 2.0 Extended

Trademark Results [OrthoPulse]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ORTHOPULSE
ORTHOPULSE
86448519 5078503 Live/Registered
BIOLUX RESEARCH HOLDINGS, INC.
2014-11-07
ORTHOPULSE
ORTHOPULSE
86173036 4960675 Live/Registered
CuraMedix, LLC
2014-01-23
ORTHOPULSE
ORTHOPULSE
79324604 not registered Live/Pending
LLLT Technologies SA
2021-08-23
ORTHOPULSE
ORTHOPULSE
76316740 2804038 Dead/Cancelled
IMD-International Market Development BV
2001-09-25
ORTHOPULSE
ORTHOPULSE
74198488 1753766 Dead/Cancelled
IMD Innovative Medical Devices B.V.
1991-08-27

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